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Saturday, August 16, 2014

Multiple Sclerosis Symptoms Aggravated By Genetic Alterations in Patients

genetic alteration in MSWhile the majority of scientists dedicated to multiple sclerosis research focus on genetic regulators of conditions such as autoimmunity, demyelination, inflammation, and neurodegeneration, a team from the University of Lubeck in Germany, led by Saleh M. Ibrahim, MD, PhD, focuses on genetic regulators of conduction velocity. The team is uncovering how certain genetic alterations aggravate disease in multiple sclerosis patients and mice with multiple sclerosis-like experimental autoimmune encephalomyelitis (EAE).
“Impairment of nerve conduction is a common feature in neurodegenerative and neuroinflammatory diseases such as multiple sclerosis,” stated Dr. Ibrahim, as reported by a press release from the publishing organization Elsevier. “Measurement of evoked potentials (whether visual, motor, or sensory) is widely used for diagnosis and recently also as a prognostic marker for multiple sclerosis.”
The gene culprit identified by Dr. Ibrahim’s group is the inositol polyphosphate-4-phosphatase, type II (INPP4b) gene. As detailed in the team’s article published in The American Journal of Pathology, “Nerve Conduction Velocity is Regulated by the Inositol Polyphosphate-4-Phosphatase II Gene,” polymorphisms, or two variants of the same gene, of Inpp4b produce different speeds of nerve conduction in multiple sclerosis patients and mice with EAE.
Dr. Ibrahim and colleagues made their discovery through several genomic approaches, including quantitative trait mapping, congenic mapping, in silico haplotype analyses, comparative genomics, and transgenic mice. After identifying Inpp4b as the gene behind the genetic locus EAE31, which was previously shown to control motor evoked potential latency and clinical onset of mouse EAE, the team analyzed the region in 8 mice strains.
Interestingly, the strains of mice could be placed into two categories based on the resultant amino acid sequence of INPP4B. One groups had the longer-latency SJL/J allele and the two amino acids arginine and proline, while the other group had the shorter-latency C57BL/10S allele and the two amino acids serine and histidine. “These data suggest that INPP4b structural polymorphism is associated with the speed of neuronal conduction,” stated Dr. Ibrahim. What’s more, mice with mutant Inpp4b had slower nerve conduction than control mice without the mutation.
Applying their findings to humans, the team investigated INPP4B polymorphisms in multiple sclerosis patients from Spain and Germany. Each group had over 300 cases of the mutation and controls (349 cases and 362 controls in Spain and 562 cases and 3,314 controls in Germany). When the cohorts were pooled, there was a statistical significance in the risk for aggravated multiple sclerosis symptoms due to a INPP4B polymorphism. However, looking at the cohorts individually, the Spanish cohort showed a significant association, while the German cohort did not. “The exact reason for the diverging effect across these populations remains unresolved,” commented Dr. Ibrahim.


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Friday, August 15, 2014

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Mallinckrodt Completes Acquisition Of Questcor Pharmaceuticals (maker of Acthar(R) Gel





-Creates a diversified, high-growth therapeutic portfolio, capable of delivering substantial, sustainable value for shareholders

- Significantly increases Mallinckrodt's scale, revenues, profitability and cash flow
- Expected to be immediately accretive to Mallinckrodt's fiscal 2014 adjusted diluted earnings per share; significantly accretive to adjusted diluted earnings per share in fiscal 2015

PR Newswire
DUBLIN, Aug. 14, 2014

DUBLIN, Aug. 14, 2014 /PRNewswire/ -- Mallinckrodt plc , a leading global specialty pharmaceutical company, today announced that it has completed its acquisition of Questcor Pharmaceuticals, Inc.  in a cash and stock transaction valued at approximately $5.8 billion. The acquisition is expected to be immediately accretive to Mallinckrodt's fiscal 2014 adjusted diluted earnings per share and significantly accretive to its adjusted diluted earnings per share in fiscal 2015.

The merger follows strong approval by both Mallinckrodt and Questcor shareholders at separate special meetings held today. Under the terms of the merger agreement, Questcor shareholders will receive $30.00 in cash and 0.897 of a Mallinckrodt ordinary share for each Questcor share.

"We are pleased to complete this transformative transaction and believe it will provide a strong, durable, well-diversified and sustainable platform, capable of generating significant future revenue and earnings growth for Mallinckrodt shareholders," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "HP Acthar(R) Gel has demonstrated success in treating patients suffering from a variety of devastating and difficult-to-treat autoimmune and inflammatory illnesses. We are confident that Acthar will be a strong complement to Mallinckrodt's broadening portfolio of leading specialty pharmaceutical brands, and we look forward to leveraging our extensive manufacturing and scientific expertise, as well as our experience with advocacy and payer communities, to capitalize on the many opportunities it presents."
Mr. Trudeau added, "We are very pleased to welcome the Questcor team to Mallinckrodt. We are excited about our future prospects and the benefits that our collective efforts will have for patients, our investors and the communities that we serve."

As previously disclosed, commercial operations supporting HP Acthar Gel will function as a separate business within Mallinckrodt's Specialty Pharmaceuticals segment reporting to Mr. Trudeau. It will be known as the Autoimmune and Rare Diseases business within Mallinckrodt.

Advisors
Mallinckrodt's financial advisor for the transaction was Barclays, and its legal advisors were Wachtell, Lipton, Rosen & Katz and Arthur Cox in Ireland.

Questcor Pharmaceuticals' financial advisor for the transaction was Centerview Partners and its legal advisors were Latham & Watkins LLP and Matheson in Ireland.

About H.P. Acthar(R) Gel








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Biogen Idec’s PLEGRIDYTM (peginterferon beta-1a) Approved for Relapsing Forms of MS - detailed information is found here


Below is a brief on the FDA approval of PLEGRIDY™ (peginterferon beta-1a), which can be used as background to educate your staff and internal team on the approval of PLEGRIDY, a treatment for relapsing forms of MS that is dosed once every 14 days, along with a link to the U.S. Prescribing Information and Medication Guide. Please let me know if you have specific questions.

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Biogen Idec’s PLEGRIDYTM (peginterferon beta-1a) Approved for Relapsing Forms of MS

The U.S. Food and Drug Administration (FDA) has approved Biogen Idec’s PLEGRIDY™ (peginterferon beta-1a) as a new treatment for people living with relapsing forms of multiple sclerosis (RMS). The approval of PLEGRIDY, the pegylated interferon beta approved for use in relapsing MS, is based off of pivotal Phase 3 data that demonstrated the safety and efficacy of PLEGRIDY complimented by an every two week dosing schedule.

PLEGRIDY is administered subcutaneously just under the skin once every two weeks. It is available via PLEGRIDY PEN, a single-dose autoinjector, or prefilled syringe. Detailed instructions on how to use PLEGRIDY will be available at PLEGRIDY.com.

The FDA approval of PLEGRIDY is based on one year results from ADVANCE, a placebo-controlled clinical trial which involved more than 1,500 people living with MS.  In the study, PLEGRIDY was shown to significantly reduce important clinical and imaging measures, including slowing the progression of disability and decreasing the number of relapses and brain lesions.

Biogen Idec plans to make PLEGRIDY available through U.S. specialty pharmacies in the coming weeks. The company is committed to providing access to PLEGRIDY and provides a variety of support services for patients and caregivers, including financial assistance programs, through MS ActiveSource®.

For more information on PLEGRIDY, including prescribing information and medication guide, go to PLEGRIDY.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

Indication
PLEGRIDYTM (peginterferon beta-1a) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS).

Important Safety Information

Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with PLEGRIDY.

PLEGRIDY can cause serious side effects. Call your healthcare provider right away if you have any of the symptoms listed below.

·         Liver problems, or worsening of liver problems including liver failure and death. Symptoms may include yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider regularly. You will have regular blood tests to check for these possible side effects
·         Depression or suicidal thoughts. Symptoms may include new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety

Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon beta-1a, or any of the other ingredients in PLEGRIDY.

Before taking PLEGRIDY, tell your healthcare provider if you:

·         Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
·         Have or had liver problems, low blood cell counts, bleeding problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease
·         Take prescription and over-the-counter medicines, vitamins, and herbal supplements
·         Are pregnant or plan to become pregnant. It is not known if PLEGRIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY.
·         Are breastfeeding or plan to breastfeed. It is not known if PLEGRIDY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY




PLEGRIDY can cause additional serious side effects including:
·         Serious allergic reactions. Serious allergic reactions can happen quickly. Symptoms may include itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, or skin bumps
·         Injection site reactions. PLEGRIDY may commonly cause redness, pain or swelling at the place where the injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected and it does not heal within a few days. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider
·         Heart problems, including congestive heart failure. While PLEGRIDY is not known to have any direct effects on the heart, some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking interferon beta. If you already have heart failure, PLEGRIDY may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY
o   Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)
·         Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta
·         Blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding or anemia, and can cause changes in your liver function tests. Your healthcare provider should do blood tests while you use PLEGRIDY to check for side effects
·         Seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before

The most common side effects of PLEGRIDY include:
·         Flu-like symptoms. Many people who take PLEGRIDY have flu-like symptoms early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. Symptoms may include headache, muscle and joint aches, fever, chills or tiredness
o   You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. For many people, these symptoms lessen or go away over time

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for additional important safety information. This information is not intended to replace discussions with your healthcare provider.







©2014 Biogen Idec Inc. 225 Binney Street, Cambridge, MA 02142. All rights reserved.

BIOGEN IDEC’S PLEGRIDY™(PEGINTERFERON BETA-1A) APPROVED IN THE US FOR THE TREATMENT OF MULTIPLE SCLEROSIS

BIOGEN ADDING another MS Medication to it's fleet 
Friday, August 15, 2014 6:32 pm EDT
− Reduces Relapses, Disability Progression and Brain Lesions with a Favorable Safety Profile −
− Only Pegylated Interferon in MS, Dosed Once Every Two Weeks –
− Complements Biogen Idec’s Industry-Leading Portfolio of MS Products –
CAMBRIDGE, Mass.Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDYTM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). PLEGRIDY, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe.
“PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “PLEGRIDY represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”
The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety of PLEGRIDY administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received PLEGRIDY for the duration of the study.
In the first year of the ADVANCE clinical trial, PLEGRIDY dosed once every two weeks significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). PLEGRIDY reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38 percent (p=0.0383) compared to placebo. PLEGRIDY also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001) compared to placebo.
The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain. The ADVANCE two-year safety data were consistent with safety results observed in year one.
“PLEGRIDY is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,” said Peter Wade, M.D., medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, CT. “As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.”
PLEGRIDY has been recently approved by the European Commission.
“It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,” said Dr. Timothy Coetzee, chief advocacy, services and research officer at the National MS Society.
For more information on PLEGRIDY, prescribing information and financial assistance programs visit PLEGRIDY.com or biogenidec.com.
About PLEGRIDY™

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Cannabis-based multiple sclerosis drug approved in Wales but could be blocked in England (UK confusion?)


Sativex, a cannabis-derived drug for treating muscle spasms in multiple sclerosis, gets green light in Wales but could still be blocked in England
GW Pharmaceuticals (Stuttgart: A1T980 - news) ' cannabis-based multiple sclerosis drug Sativex will be made widely available in Wales, but could still be blocked in England.
The Welsh medicines board on Friday confirmed it had recommended Sativex to relieve muscle spasms in multiple sclerosis, as first reported in the Telegraph earlier this week.
Dr Sajida Javaid, a consultant in rehabilitation medicine at Neath Port Talbot Hospital hailed the Welsh recommendation as a "significant milestone for the treatment of spasticity".

Sativex was first launched in the UK in 2010, but patients have only been able to access the treatment on an ad hoc basis since, until now, authorities had issued no clear guidance on the use of the drug.



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Promising Multiple Sclerosis Research Partnership Between Biogen Idec, Regulus Renewed


Biogen IdecRegulus Therapeutics, Inc., a San Diego-based biopharmaceutical company that specializes in the research and development of experimental drugs that target microRNAs, recently announced that it has signed a contract to work together with Biogen Idec. Under Regulus’ microMarkers™ project, the two companies will be collaborating on research efforts to discover microRNAs that can serve as biomarkers for multiple sclerosis (MS).
This new collaborative research venture will center on studying a substantial amount of blood samples from a group of individuals with MS. These patients were previously prescribed a Biogen Idec MS treatment designed to recognize the probability of microRNA signatures. The new contract between the two drug developers entitles Regulus to an upfront payment of $2 million as well as a series of separate payments during the course of the agreement after completion of particular research milestones.
The two companies launched their partnership two years ago, in August 2012. Regulus utilized its patented technology to obtain, describe, and analyze these microRNAs from small blood samples in order to build an extensive profile of more than 400 samples from patients diagnosed with MS, which they then compared to those from healthy individuals. The outcome of these investigations formed the foundation of the scope of their new tandem research with Biogen Idec.


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Thursday, August 14, 2014

From Pensacola, Florida- A Look at the Invisible Symptoms of MS

Location: Pensacola, Florida
Recording Date: August 9, 2014






Presented by: Brian Steingo, MD of Neurology
Provided by: MS Views and News




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Anti-psychotic drugs to be used in Multiple Sclerosis study

  • Kiwi researchers have been given the greenlight to use anti-psychotic multiple sclerosis patients. (Source: ONE News)
    Kiwi researchers have been given the greenlight to use anti-psychotic multiple sclerosis patients. - Source: ONE News
August 14, 2014
New Zealand researchers have been given the green light to trial new treatments on multiple sclerosis patients using anti-psychotic drugs.
The researchers from Victoria University believe they may be able to reduce the symptoms of this debilitating disease using commonly prescribed drugs.
They say a lower dosage of Clozapine and Risperidone, which treat depression and schizophrenia, can be used to treat MS.
Victoria University researcher Dr Laura Green says the study shows that using the drugs are reducing inflammation and even stopping inflammation in its tracks.
Dr Anne La Flamme says while there are drugs for people who suffer relapses, there has been nothing for those whose condition is progressive.
"It's a different pathway, different way that they are treating MS as to how they would be treating schizophrenia," she says.
"To be able to do something that may benefit them directly is invaluable."
Read More





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Invisible Symptoms of MS, Relapse plus Dietary and Self Aspects



Video Recorded July 29th, 2014 from Boca Raton, Florida
With Brian Steingo, MD of Neurology





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Optic Dysfunction with Multiple Sclerosis



Video Recorded on July 29, 2014









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Wednesday, August 13, 2014

Understanding - Accurate Diagnosis

MS Atrium: Accurate Diagnosis View a presentation on diagnosing Multiple Sclerosis accurately

CLICK:



MRI scan of a brain with multiple sclerosis







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MS Prognosis Roundtable - a video discussion with a few MS Experts

I was on www.msatrium.com and thought this would be of interest to you.


Watch this easy to understand video found here







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Gene that controls nerve conduction velocity linked to multiple sclerosis

Evidence found in both human multiple sclerosis patients and experimental mouse models, according to research published in the American Journal of Pathology

Philadelphia, PA, August 13, 2014 – A new study published in The American Journal of Pathology identifies a novel gene that controls nerve conduction velocity. 

Investigators report that even minor reductions in conduction velocity may aggravate disease in multiple sclerosis (MS) patients and in mice bred for the MS-like condition experimental autoimmune encephalomyelitis (EAE).

A strong tool for investigating the pathophysiology of a complex disease is the identification of underlying genetic controls. Multiple genes have been implicated as contributing to the risk of developing MS. Unlike studies that have focused on genetic regulators of inflammation, autoimmunity, demyelination, and neurodegeneration in MS, this study focused on nerve conduction velocity. Investigators found that polymorphisms of the inositol polyphosphate-4-phosphatase, type II (Inpp4b) gene affect the speed of nerve conduction in both mice with EAE and humans with MS.

"Impairment of nerve conduction is a common feature in neurodegenerative and neuroinflammatory diseases such as MS. Measurement of evoked potentials (whether visual, motor, or sensory) is widely used for diagnosis and recently also as a prognostic marker for MS," says lead investigator Saleh M. Ibrahim, MD, PhD, of the Department of Dermatology, Venereology, and Allergology of the University of Lubeck (Germany).

Using several genomic approaches, the investigators narrowed their search to the genetic region controlling the enzyme inositol-polyphosphate-4-phosphatase II (INPP4B), the product of which helps to regulate the phosphatidyl inositol signaling pathway. Enzymes in this family are involved in cellular functions such as cell growth, proliferation, differentiation, motility, survival, and intracellular communication.

In one series of experiments, the researchers analyzed the genetic locus EAE31, which previously had been shown to control the latency of motor evoked potentials and clinical onset of EAE in mice. Using advanced techniques including congenic mapping, in silico haplotype analyses (computer simulations), and comparative genomics (from rats, mice and humans), they were able to "finemap" the focus to Inpp4b as the quantitative trait gene for EAE31.

When the investigators analyzed this region in eight different strains of mice, they found they could divide the strains into two groups based on differences in amino acid sequences. The strains with the longer-latency SJL/J allele had the two amino acids (arginine and proline), whereas those with the shorter-latency C57BL/10S allele had others (serine and histidine). "These data suggest that Inpp4b structural polymorphism is associated with the speed of neuronal conduction," comments Dr. Ibrahim.

In another experiment, the scientists compared motor conduction velocity in genetically modified mice with a mutant Inpp4b gene to that of control mice. The nerve conduction in this group was slower than in the control group.

Finally, the investigators studied INPP4B polymorphisms in MS patients. They looked at two cohorts: one from Spain (349 cases and 362 controls) and a second from Germany (562 cases and 3,314 controls). The association between the INPP4B polymorphisms and susceptibility to MS was statistically significant when the cohorts were pooled. However, although the Spanish cohort showed a strong association between INPP4B and MS, the association was weaker in the German cohort. "The exact reason for the diverging effect across these populations remains unresolved," states Dr. Ibrahim.

In an accompanying commentary, Hans Lassmann, MD, of the Center for Brain Research of the Medical University of Vienna (Austria) notes, "This study represents an interesting example of how minor changes in conduction velocity, which do not result in a clinical phenotype in control populations, may aggravate disease in conditions such as EAE or MS." In other words, impaired nerve conduction may have a greater impact on those with MS compared to healthy individuals. Noting that the study reported no major loss of myelin in animals carrying the mutant allele, Dr. Lassmann comments that it is still unclear which neurobiological mechanisms underlie the INPP4B-associated impaired conduction. One suggestion is that INPP4B may be involved in calcium ion signaling within synapses, affecting neurotransmitter release


Contact: Eileen Leahy
ajpmedia@elsevier.com
732-238-3628
Elsevier Health Sciences 

Article source found here


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Sunday, August 10, 2014

11 minute video about MS Views and News

To watch this 11 minute video, click here 

Maybe this is a little long, yes we do understand, but it does provide a little info about MS Views and News, for the many who do not know all that we are doing for the MS Community











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How To Raise Your Love and Healing Hormone: A Science Based Perspective

How to Naturally Raise Your Oxytocin Levels for optimal growth, healing, relationships, and relaxation.
Oxytocin is a neurotransmitter and a hormone that is used for so much more than just labor and childbirth.  In the past 20 years there has been more and more research studies that have revealed the many different functions and benefits of this very important substance.  Though most studies to date have been done on animals, we may still greatly benefit from a deeper understanding of the importance of stimulating the release of this vital “love, connecting, healing, and self-growth stimulating” hormone in our everyday lives and relationships. Oxytocin is low in many chronically ill conditions according to studies such as chronic pain, depression, autism, schizophrenia and alchoholism.
Energy HealingLOVE
What is Oxytocin?
Oxytocin which means “quick labor/birth” is both a neurotransmitter (signaling substance in the brain) and a hormone (acts in the body through the bloodstream) in the body that is involved with calming, releasing, connecting, growth, reproduction, healing, socializing, friendliness, curiosity, digestion, trust, and a recharging of energy.
 



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