FDA takes steps to aid in the development of abuse-deterrent opioids
The U.S. Food and Drug Administration issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations, ADF, while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today's actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. "For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care," said FDA Commissioner Robert Califf, M.D. "We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy." In today's guidance, the agency is encouraging industry efforts to develop pain medicines that are more difficult to abuse. Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding. It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death - notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole. Companies whose stock performance may be affected by this include Collegium Pharmaceutical (COLL), Egalet Corporation (EGLT), Elite Pharmaceuticals (ELTP), DURECT Corporation (DRRX), KemPharm (KMPH) Acura Pharmaceuticals (ACUR) Cara Therapeutics (CARA) and Zogenix, (ZGNX
