New OxyContin Formulation and Generic Alprazolam Approved
Posted by Dr. Julia Harder
New OxyContin Formulation Approved
The FDA has approved a new formulation of OxyContin (Purdue Pharma) designed to discourage medication misuse and abuse. The reformulated OxyContin is intended to prevent the product from being cut, broken, chewed, crushed or dissolved to release more medication. This formulation may result in less risk of overdose due to tampering, likely resulting in less abuse by snorting or injection.
However, according to Dr. Bob Rappaport, director of the FDA's Division of Anesthesia and Analgesia Products, the new formulation provides only an "incremental advantage" over the current version of the drug. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."
Many addiction experts are skeptical about how tamper-resistant the new formulation will prove to be. According to the FDA, Purdue Pharma will be required to conduct post-marketing analysis on how - or if - the new formula reduces abuse of the drug.
FDA News Release on New OxyContin Formulation
Generic Alprazolam Orally Disintegrating Tablets Approved
The FDA has granted market approval to Actavis Group for alprazolam 0.25, 0.5, 1, and 2 mg orally disintegrating tablets, indicated for the management of anxiety disorder and the short-term relief of anxiety symptoms. The medication is generically equivalent to Niravam (Schwarz Pharma). The company will begin distributing the product immediately.