nannamom
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Age : 66
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Registration date : 2008-11-09
 | | Subject: Update on implants for the treatment of addiction Fri 10 May 2013, 2:35 pm | |
| A panel for the FDA that once given approval for the new implant "Probuphine" for the treatment of addiction has now rejected Probuphine. Please see the previous news article dated April 22nd, HERE
Since that article there have been some questions as to the dosing strength for probuphine and with great cause. After reading that article I myself did some math just to see how much medication would be delivered into the patients body on a daily basis.
Each rod contains 80 mg. of buprenorphine, there are 4 rods bring that to a total of 320 mg of buprenorphine to be released over a 6 month period. In the previous article it stated that this would be enough medication to sustain a patient taking 12-16mg of buprenorphine a day. But as we all know, not everyone currently takes 12-16 mg a day.
Frankly I don't see where they came up with that figure. Do the math and please correct me if I am wrong. But by what I can tell with those numbers the amount of Buprenorphine released into a patients system over time would be about 1.7 mg per day. Not 12-16 mg.
At any rate the panel who at first approved has now rejected. Read the article below: 
Titan Pharmaceuticals Inc. (TTNP) plunged the most in 17 years after the company failed to win U.S. regulatory approval for an implant to treat addiction to heroin and prescription painkillers.
Titan fell 74 percent to 43 cents at 4 p.m. New York time, the biggest drop since January 1996 when the company began offering public shares. The Food and Drug Administration asked for more information to prove the matchstick-size implant called Probuphine for opioid dependence works, the company said in a statement yesterday. The FDA wants additional data on the effect of higher doses of Probuphine and training for doctors on insertion and removal of the implant.
Probuphine may generate $360 million in sales in 2018, Michael Higgins, an analyst for Brinson Patrick Securities Corp., said in an e-mail before the rejection. Titan, based in South San Francisco, California, licensed the U.S. and Canadian rights to Apple Tree Partners’ Braeburn Pharmaceuticals. Titan is eligible for a $50 million milestone payment on approval.
“Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA’s response,” Marc Rubin, executive chairman of Titan, said in the statement.
Titan believes Probuphine demonstrated both safety and efficacy and meets a “critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure,” Rubin said.
A panel of FDA advisers that gave Probuphine a positive recommendation in March raised concern that the dose of the active ingredient, buprenorphine, may have been too low and questioned the adequacy of the physician training program.
Article Source:Bloomberg Business WeekA special thank you to Ellen/BlueEyes for doing the great research in locating the above news article.
Ellen | |
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