Industry Briefs

HHS Announces Actions to Expand Opioid Treatment, Combat Misuse

The Department of Health and Human Services (HHS) last week announced several new actions to address the nation’s opioid crisis, including expanding access to buprenorphine treatment, a proposal to eliminate any possible financial incentive to overprescribe opioids, and a requirement for Indian Health Service practitioners to check state Prescription Drug Monitoring Program (PDMP) databases.

The department’s new rule on buprenorphine treatment increases the number of patients a specially trained physician can treat from 100 to 275. Addiction specialists and those who practice in a qualified health setting will be eligible for the higher patient limit after they have held a Drug Enforcement Administration waiver for the 100-patient limit for at least a year.

The department also plans to launch more than a dozen new scientific studies on opioid misuse and pain treatment while soliciting feedback to improve and expand prescriber education and training programs.

FDA Advisory Panel Recommends Approval of Two Abuse-Deterrent Opioids

A Food and Drug Administration advisory panel in June recommended the approval of two long-acting opioid analgesics designed to deter abuse.

The panel voted 14 to 3 in favor of approving Ventrala ER (hydrocodone bitartrate) by Teva Pharmaceuticals Inc. 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.” The panel also favored labeling claims that Ventrala ER formulation can help to prevent abuse through oral, nasal, and intravenous routes.

In a vote of 9 to 6, Pfizer’s Troxyca ER (oxycodone/naltrexone) was recommended for the same indication as Ventrala ER. Although the panel agreed the formulation can prevent abuse by intravenous and intranasal routes, it rejected the label claim that the product could prevent abuse of the drug via the oral route. ■