Newswires
Key FDA Committee Recommends Buprenorphine Implant  E-mail
Addiction Treatment Industry Newswire

01/14/2016 -ATIN - The stock of tiny specialty drug manufacturer Titan Pharmaceuticals (TTNP: Nasdaq) has been highly volatile on very heavy volume since a key committee of the FDA on Tuesday recommended approval of a buprenorphine implant Titan has developed in partnership with Braeburn Pharmaceuticals, another specialty pharma house controlled by the investment group Apple Tree Partners. The buprenorphine implant, which is called Probuphine, resembles a matchstick in size and would be implanted in individuals and deliver controlled dosages of the drug on a daily basis over a six month period.

Not Guaranteed Approval

Probuphine was examined by a committee of experts that has recommended that the FDA ultimately approve the drug for production and then use by the general public. The FDA more often than not accepts the recommendations of these expert committees, but is not obligated to do so and sometimes surprises by going against committee recommendations. A quote in an article in the New York Times we think accurately sums up the dilemma in ultimately approving the implant: "There is not significant evidence of risk using this agent, but there is evidence of significant benefit," Maryland Dept. of Mental Health and Hygiene Staff Psychiatrist Dr. Thomas Grieger told the newspaper.

Suboxone Basically Replacing Methadone

Suboxone, which Drugs.com said was the 39th largest selling drug in the world in recent years, was a huge blockbuster drug selling for years in excess of $1B annually worth of the drug worldwide - in 2014, when developer Reckitt Benckiser spun off the unit to shareholders in a tax-free transaction - sales fell by 8 percent to $1.1B. Suboxone, which contains the anti-opiate agent Naloxone in order to prevent abuse, has basically replaced methadone as the preferred method of detoxing those addicted to opiates. And despite its MUCH higher cost, has also surpassed methadone as a maintenance therapy. Buprenorphine is preferred by addiction medicine specialists because of the "ceiling effect" it has on euphoria - no matter how much you take the drug will only get a user so high (those who have high opiate tolerance feel virtually no euphoric effect from buprenorphine). At the same time, though, buprenorphine's opiate properties bind to opiate receptors and prevent and ease withdrawal symptoms during opiate detox.

FOR a CHART DEMONSTRATING  THE "CEILING EFFECT" and more on buprenorphine's history SEE OUR SPECIAL REPORT

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