FDA Approves Opioid Treatment

The FDA has approved Teva’s Vantrela ER (hydrocodone bitartrate) extended-release tablets, a long-term opioid treatment that is indicated for the management of severe pain for which alternative options are inadequate. Vantrela ER will be available as 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg strength dosages, according to prescribing information.

Vantrela ER’s approval is based on results from a clinical program that evaluated the drug’s safety and efficacy, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies. The drug was formulated with Teva’s proprietary abuse deterrence technology, according to a prepared statement from the company.

The product’s abuse-deterrent properties are expected to reduce, although not completely prevent, oral, intranasal, and intravenous abuse of opioid tablets. Vantrela ER’s prescribing information contains a boxed warning that includes addiction, abuse, and misuse warnings.

Adverse effects observed in patients in placebo-controlled clinical trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.

Reference

Teva Receives FDA Approval for Vantrela ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology [news release]. Jerusalem. Teva website. http://www.tevapharm.com/news/teva_receives_fda_approval_for_vantrelatm_er_hydrocodone_bitartrate_extended_release_tablets_cii_formulated_with_proprietary_abuse_deterrence_technology_01_17.aspx. Accessed January 18, 2017.