Industry Briefs

FDA Advisory Panel Recommends Approval of Drug With Abuse-Deterrent Properties

A Food and Drug Administration (FDA) advisory panel in August voted 18-1 to recommend the approval of Arymo ER, an extended-release morphine formulation indicated “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the company. Most panel members also voted that, if approved, Amyro ER should be labeled as an abuse-deterrent product when delivered by oral, nasal, and intravenous routes.

The recommendations were based on data presented from five phase 1 pharmacokinentic studies as well as two phase 3 human abuse liability studies. The abuse liability trials revealed that “drug liking” was significantly reduced when Arymo ER was manipulated compared with that of crushed MS Contin, an approved extended-release morphine formulation.

The FDA is not bound by the recommendations of its advisory panels, but will consider the guidance during the review of the new drug application for Arymo ER. The company said it expects to hear a decision from the FDA by October 14.

Impax Laboratories Recalls Lot of Lamotrigine Orally Disintegrating Tablet

Impax Laboratories Inc. announced last week that it had issued a voluntary nationwide recall for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg after the company learned that blister packs may contain the 100 mg product instead of the 200 mg product.

“Each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT; however, the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT,” according a company release. “Shell packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose.”

The affected lot—NDC Number 0115-1529-08; lot number 502240—was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide. ■