Pfizer's marketing application for ALO-02, an extended-release, abuse-deterrent formulation opioid for pain management, was accepted for review by the FDA. The drug, taken orally, is a combination of oxycodone hydrochloride and naltrexone hydrochloride. The filing was based on data from two late-stage trials involving patients with moderate to severe chronic pain not caused by cancer.
Par Pharmaceutical's generic formulation of GlaxoSmithKline's Wellbutrin XL drug for depression in the 300-milligram strength has received approval from the FDA. The company also announced that it already started marketing the 150-milligram version of the generic bupropion hydrochloride extended-release tablet.
Pain patients and people who lost family members to addiction were among the groups represented at an FDA hearing on a petition on the labeling of opioid drugs. A petition from Physicians for Responsible Opioid Prescribing calls for restrictions on the marketing and use of opioid painkillers, including for moderate noncancer pain. Other groups said the proposal could block access to opioid drugs for patients with legitimate pain and that there are challenges in attempting to distinguish cancer pain and noncancer pain due to the long-term complications of the disease.
The FDA gave Sun Pharmaceutical Industries tentative approval to market a copy of Rilutek, Sanofi-Aventis' treatment for diseases of the central nervous system. The generic, which contains riluzole hydrochloride, will be sold as a 50-milligram tablet.