Purdue Pharma Receives FDA Approval for Abuse-Deterrent HydrocodoneBy
Purdue Pharma L.P. reports that the US Food and Drug Administration (FDA) has approved Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, an extended-release (ER) opioid analgesic with abuse-deterrent properties to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product's abuse-deterrent properties consistentwith the FDA's 2013 draft guidance for industry, Abuse-Deterrent Opioids â€“ Evaluation and Labeling.
Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult although abuse of Hysingla ER by these routes is still possible.
The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community. In addition, Hysingla ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe extended-release/long-acting opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.
Purdue expects to launch Hysingla ER in the United States in early 2015 in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg to be taken once every 24 hours.
Source: FDA and Purdue Pharma