New Maoi Patch

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The Food and Drug Administration today approved Emsam selegiline, the first skin transdermal patch for use in treating major depression. The once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression.

Emsam provides a significant advance because at least in its lowest dose patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors, said Dr. Steven Galson, Director for the Center for Drug Evaluation and Research.

Major depressive disorder is a common psychiatric condition in the U.S. population. Symptoms of depression include general emotional dejection, withdrawal and restlessness that interfere with daily functioning, such as loss of interest in usual activities; significant change in weight and/or appetite; insomnia; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and a suicide attempt or suicidal ideation.

MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase in blood pressure, or hypertensive crisis. A hypertensive crisis can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats palpitations, sweating, and confusion. Patients who have these symptoms should get medical care right away.

The lowest dose of the MAOI patch, which delivers 6 milligrams mg of the medication over a 24 hour period, can be used without such dietary restrictions.

The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours. The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.

Emsam has been shown safe and effective for treatment of major depressive disorder in two 6-8 week studies and also in a longer-term study of patients. The data for EMSAM 6mg/24hr support the recommendation that a modified diet is not required at this dose. Patients are advised to change the patch once a day. The more limited data available for EMSAM 9mg/24hr and 12mg/24hr do not rule out food effects so that patients receiving these higher doses should follow dietary restrictions that advise them to avoid certain foods or beverages. This includes foods and beverages such as aged cheese and wine.

The only common side effect of Emsam detected in placebo-controlled trials was a mild skin reaction where the patch is placed. There may be mild redness at the site when a patch is removed. If the redness does not go away within several hours after removing the patch or if irritation or itching continues, patients are advised to contact their doctor.

Another side effect that was seen less commonly was light-headedness related to a drop in blood pressure.

The manufacturer and distributor of this new product have planned an educational campaign for patients and prescribers to ensure that advice on dietary modifications for the higher patch strengths is adhered to. They plan to conduct both patient and health care provider surveys to assess the effectiveness of the educational campaign. The manufacturer and distributor will also closely track reports of adverse events, and follow-up on those that might represent hypertensive crises, to further ensure the safe use of this product.

Although the effects of heat on the patch are not known, the drug labeling advises health care professionals and patients about the possible effects of direct heat applied to the Emsam patch. Direct heat may result in an increased amount of the drug absorbed from the patch. Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight.

Like all approved antidepressants, this product carries a warning of increased suicidality in children and adolescents.

EMSAM was developed by Somerset Pharmaceuticals, Inc. In December 2004, Bristol-Myers Squibb and Somerset entered into an agreement that provides Bristol-Myers Squibb with distribution rights to market EMSAM after approval in the United States. Selegiline was initially approved in capsule form for use in Parkinson s Disease.

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EMSAM is the first and only once-daily skin patch approved to treat major depressive disorder MDD. See full prescribing information for EMSAM.

Monoamine oxidase inhibitor New research into MAOIs indicates that much of the concern over their dangerous A transdermal patch form of the MAOI.

Just to set the record straight, ESAM is to neither be generic nor be available outside of the United States anytime soon. Emsam was developed by Somerset pharmaceuticals the name EMSAM being derived from a combination of the current CEO s children; Emily and Samuel. The patch is manufactured and distributed by Bristol-Myers Squibb Company out of New Jersey. It is currently under the protection of a patent that prevents any generic Emsam from being manufactured in the United States. Yet, if you search the Internet for generic Emsam, you may find a number of companies selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. There may be generic Emsam available from another country, but there is really no way of knowing if you are getting genuine Emsam or not. You should not buy any generic Emsam until there is an approved generic available.

When Will Generic Emsam Be Available.

The first patent for Emsam currently expires in 2018. This is the earliest possible date that a generic version of Emsam could become available. However, other circumstances could come up to extend the exclusivity period of Emsam beyond 2018. These circumstances could include things such as other patents for specific Emsam uses or lawsuits. Once Emsam goes off patent, there may be several companies that manufacture a generic Emsam drug.

So unfortunately, anyone that wants to use the med on a long-term basis had better have some superb insurance. The out of pocket cost is exorbitant and shame on Bristol Meyers Squibb and Big Pharma for blatantly stealing from the pockets of hardworking Americans. Shame on you Squibb and Mel Sharoky, M.D., CEO of Emsam. Modern day pirates in white coat disguise is what you lot are.

The thought of shelling out 600 dollars a month in nauseating: I have been on the patch for three months and could have bought a top-notch Sony Bravia Entertainment system by now. Clearly, I value my mental health more and clearly, the patch is working. It is a PANACEA of a drug but does require proper tweaking and often requires certain adjuncts to benefit fully from the medication.

The real key to success with EMSAM is to first tweak the starting dose. Starting at 6mg/24 hours was a mistake on Squibb s part. The dose should be 3mg/24 to start out. Fortunately, yes, you can cut the patch in half despite what the attached pamphlet that comes with your script designed for legality reasons says or what your doctor or pharmacist might say. My pharmacist told me not to cut the patch b/c its pressure sensitive. Say what. Please. Transdermal delivery technology has been around for decades. Not that complicated. People cut Nicotine patches all the time.

More importantly, I ended up sacking up and cutting the patch in half for the first month. Worked like a charm. I then skipped 6mg and went straight to 9mg. This is important, as I will explain below. Went on 9mg patch for a month before reaching what I have long been searching for, happiness in pharmaceutical form at 12mg. It is at 12mg that the patch begins to act like a true MAOi, mimicking the highly effective but side effect saturated drugs, Nardil and Parnate. More like Parnate without the anxiety and Nardil without the cognitive dulling due to GABA overload. No weight gain, no sexual dysfunction, no acne; this drug is perfect in every way, wellas long as you know how to tweak it which I will again, explain below.

Why start at 3mg. At this low dose, you are only inhibiting MAO-B and thereby boosting only dopamine. Sometimes this is all people need and there is no need for them to trek any further. Still, at 3mg, the dopamine boost is not overly excitatory. It is only at the dreaded 6mg dose where you run into dopamine overload. This is because at 6mg you probably quadruple exogenous dopamine levels but barely scratch the surface of MAO-A so serotonin and norepinephrine boostage is minimal. The 6mg problem is this: the ratio of MAO-B to A is off. Now, if you are someone severely lacking in dopamine, then 6mg may be your ideal dose but for most, there is too much MAO-b inhibition and not enough A to counteract the stimulatory effects of the massive flux of dopamine. Thus, people are turned off by EMSAM b/c too much dopamine can make one feel anxious, uncomfortable, socially awkward, and paranoid. It is not until nine, but most often 12 mg that the proper ratio of MAO-B to A reaches full efficacy. Contradictory to what one might assume, increasing the dose has a calming effect. I imagine that higher doses would achieve the efficacy rating of the old school MAOis, Nardil and Parnate. I have strapped on two 12mg pathces and the effect was positive but not financially feasible.

Another reason people have issues with EMSAM is that they are unaware that the major and most common side effect of all MAOs is hypotension decreased blood pressure. Most doctors do not even know this. Hypotension causes one to feel tired, brain fog, dead legs etcI have MAOi induced hypotension and yes, there is a cure. Although considered taboo, it is common practice by knowledgeable psychopharmacologists to prescribe a low dose of either Dextroamphetamine, Methamphetamine Desoxyn or Methylphenidate Ritalin as an adjunct. I currently take 15 mg of Desoxyn with ESAM to boost my blood pressure back to normal 116/76. Without Desoxyn, ESAM would be useless for me b/c it drops my BP to 84/32. Without ESAM, Desoxyn would be useless b/c it elevates my BP to 147/90 and makes me anxious. They are however, a beautiful combination.

Am I crazy. talking about using stims with a MAOi. Most people think MAOi and stimulant and then think hypertensive crisis. Most docs would frown upon this combo simply b/c they know nothing of it; it requires outside the box thinking to even grasp combing and MAOi with a stim. How can a doctor grasp such an idea when they have spent years, sodomized by their superiors, to think inside the box. Study, Study, Memorize, Memorize, Robots in disguise, 72 hour shift, Sleep, Eat, Work. Therefore, they step out of their little office and look up EMSAM in their little medical dictionaries and there in bold print, it reads do not combine with stimulants. Lazy physicians rely upon that little medical dictionary written, again, for legality purposes, not medical for all their answers. It s like a bible of sorts. Outside the box thinking leads to lawsuits so hospitals cannot have their doctors getting all creative. Society only affords private practice docs such autonomy. NOTE: Ask your current doc to draw the mechanism of MAO inhibition for you; if he cannot then it is time for you to see a new doc. As for hypertension, I would not add a stimulant if blood pressure were normal or high even. High BP folks need to stay clear of stims. If anything, EMSAM will lower your BP to normal. However, as of Nov 2009 according to biopsychiatry.com there have been no reported hypertensive crises due to the patch at 6, 9 or 12 mg. This says a lot about the safety of this drug.

Nevertheless, it is for the reason that MAOi hypertensive hysteria still exists within the medical community many of which are total retards drafted fresh out the Caribbean Schools due to doctor shortage that Squibb is able to charge 600 dollars for a month of product that must cost, at max cost 50 cents, to manufacture. The demand for the drug is relatively small. It has yet to reach a mainstream audience, still considered an exotic medication, and privy to only the wealthy and medication savvy celebrity. Most MDs have not even heard of EMSAM and if they have, will not feel comfortable scripting it b/f you have tried every other dead end of a medication on planet earth. It requires doling at the big bucks and seeing a private practice psychopharmacologist at a big University such as Stanford. That or rolling into Beverly Hills for an appointment before finding someone who truly understands the patch and can confidently prescribe it along with the adjuncts that it needs to be rendered truly effective: such as a stimulant and often a benzo like klonopin. EMSAM/ low dose Lamictal combo therapy is becoming more common amongst the elite. I currently take 12mg of EMSAM, 15mg Desoxyn, 35mg Lamictal chewable, and 1mg Klonopin. This is a combination that I have been searching for, for a long time. It works ridiculously well for me.

Unfortunately, I can no longer afford it which is why I came on this forum, wondering if anyone had any spare patches lying around that they wouldn t mind sending my way. There seem to be so many people that dislike the drug, gosh, I d hate to think that the patches just lay around and collect dust at someone s house or worse, get thrown away, when there are many people out there that could desperately make good use of them. I ran into one women recently whose insurance covers the patch and her copay is 25 dollars. This made me furious. Here I am, rolling out 6 bens a month, not to mention the 400 dollar Desoxyn fee that insurance companies wouldn t cover if the survival of their left vas deferens depended upon it. It s funny how the most effective drugs are the most difficult to get hold of. They re difficult to get hold of b/c they actually work, and often too well, making them highly addictive. God forbid everyone in America, land of the free, home of the brave where everyone is afforded equal opportunity yeah rightthe US is more of an elitist nation than the United Kingdom but we re still in the closet about that be running around, pumped up on superhuman drugs. Who would work at Taco Bell. Who would wash my crappy car. Who would do all the dirty little jobs that no one likes to talk about that are reserved for foreigners and the mentally ill and for people that can t afford the necessary meds to get them out of the junk yard job funk they re stuck in and don t know why that just do it to get by.

America would cease to function in a utopia where everyone was afforded to feel just great. They ll have to settle for a bowl of corn flakes or Prozac or Adderall. Big Brother has decided that these crude medications are good enough for the Cretans to get the job done but riddled with enough side effects to keep them at bay and from ever climbing up in the social hierarchy of trees and branching outside of their class. This must change and Obama certainly isn t doing anything about it. You can t do anything about it if you don t understand it and the only way to understand it is to live and breathe it. Unfortunately, the people that live and breathe are mentally ill or have severe issues I mean. I m not really sure if Obama truly understands the healthcare situation. Healthcare in this country makes me want to yak. Sure it s good but it could be so much better for so many people. It s just not fair. Ignorance is bliss and sometimes I wish I never knew that the current combo of meds I m on even existed. Sort of feel the same way about coca leaves. Beautiful plant, best thing on earth for boosting mood but not readily attainable in this country so why bother knowing about it you know. Anyone have any spare patches or coca leaves for that matter while i m asking hahaha.

EMSAM/new MAOI patch question about when to start. Posted by RetiredYoung on March 6, 2006, at :33. Hello - With the newly approved EMSAM, I understand.

Emsam selegiline transdermal system is the trade name of an antidepressant of the monoamine oxidase inhibitor MAOI class. Emsam is a transdermal patch.

New MAOI Patch - posted in Medications: Posting, asking and sharing: Has anyone here ever used or heard of the new maoi patch. They have used this medicine in.

Let s return to the FDA decision to limit the removal of MAOI dietary restrictions for the 6 mg patch only, thus creating the complicating situation for clinicians.

Re: EMSAM/new MAOI patch question about when to start. Posted by rvanson on March 7, 2006, at :55. In reply to EMSAM/new MAOI patch question about when.

Apr 08, 2013  FDA Approves Emsam Selegiline as First Drug Patch for Depression Lowest Dose can be used without Restrictions Required of MAOIClass of Depression.