Opioid Dependence Implant Clears FDA Hurdle


In one of the final steps before marketing can begin, the U.S. Food and Drug Administration Psychopharmacology Drugs Advisory Committee cited a favorable cost-beneift profile and recommended Probuphene for approval.

This is not the final step, but a significant one, as announced in a Titan Pharmaceutical press release.

Advantages of Probuphene

The new formulation of buprenorphine will be a subdermal implant (placed under a patient’s skin), giving Probuphene some advantages in the treatment of opioid dependence. The primary advantage, and the one that put this drug in the FDA’s priority review program, is the long-lasting effects obtained without additional dosing or direct physician supervision.

“We are pleased the Committee recognized the favorable benefit-risk profile of Probuphine and voted in strong favor of its approval,” said Kate Glassman-Beebe, Ph.D., executive vice president and chief development officer of Titan.

How It Works

The active ingredient, buprenorphine, is already in use as a maintenance treatment for those in recovery from narcotic addiction, primarily heroin. Available dosage forms are a sublingual tablet or strip (used for addiction treatment), a transdermal patch and by injection (for pain relief).

With a subdermal implant, a constant level of buprenorphine can be maintained up to six months. Patients do not have to remember to take the drug and cannot go off it without removing the implant. The technology used is to create a matrix containing the drug. The active ingredient travels slowly out of the matrix, and the drug is then continuously released. Implants are commonly placed under the skin of the upper arm. The empty matrix has to be removed after six months and replaced to continue treatment.

Titan is not claiming that their new formulation works better than existing products, but studies show it is well-tolerated and offers advantages in patient compliance. With relapse a major concern in opioid dependence treatment, patients cannot always be counted upon to continue treatment. An implant overcomes this concern.

After full approval by the FDA, Probuphene will be marketed in the U.S. and Canada under a licensing agreement with Braeburn Pharmaceuticals.

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