The US Food and Drug Administration (FDA) has approved an extended-release (ER) hydrocodone bitartrate product (Vantrela ER, Teva Pharmaceutical Industries Ltd) for pain management, the company has announced.
The product is indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatments are inadequate. It incorporates novel abuse-deterrent technology designed to resist drug extraction via the most common routes: oral, intranasal, and intravenous.
Approval was supported by a clinical program that evaluated 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 company said.
The product's abuse-deterrent properties are expected to reduce, but not totally prevent, oral, intranasal, and IV abuse of the drug when the tablets are manipulated, the statement notes. It adds that as an opioid, Vantrela ER is associated with serious risks; the prescribing information contains a "boxed warning" that includes addiction, abuse, and misuse, which can lead to overdose and death, as well as serious, life-threatening, or fatal respiratory depression.
The FDA approval follows a recommendation last year by a joint FDA advisory committee to approve Vantrela ER. The joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee also advised that labeling for the oral, intranasal, and IV versions of the drug reflect its abuse-deterrent properties.
During that June 2016 advisory committee meeting, attendees heard evidence of Vantrela ER’s effectiveness, safety, and tolerability. Teva’s pivotal 12-week, double-blind, phase 3 study of patients with moderate to severe lower back pain found that those receiving the drug experienced significant pain reduction compared with those receiving placebo (P < .001).
There were no unexpected safety concerns, and the safety profile (which included constipation and nausea in some patients) was consistent with that associated with hydrocodone and other extended-release opioids.
Manipulation Studies
Experiments testing the formulation when exposed to physical and chemical manipulation showed that Vantrela ER retains its extended-release properties compared with opioid formulations that do not incorporate abuse-deterrent technology, the committee heard.
Evidence also showed that healthy recreational drug users had a significantly lower "drug liking," "overall liking," and "willingness to take the drug again" with respect to the product in oral and intranasal formulations ? the two most common routes of administration in cases of abuse ? compared with agents that are not formulated to deter abuse.
While giving the nod to Vantrela ER, many advisory panel committee members did express the view that outcome measures used in testing the efficacy of such drugs should extend beyond just pain.
In April 2015, the FDA issued guidelines to assist industry in developing opioid drug products with potential abuse-deterrent properties. The guidelines include information on how studies should be conducted to demonstrate that a given formulation has abuse-deterrent properties and makes recommendations about how these studies should be performed and evaluated.
The FDA has launched a multiyear action plan aimed at tackling abuse and misuse of prescription opioids. The plan will focus on new and existing policies to help curb abuse, addiction, and overdose of these drugs while continuing to make them available to patients in need of effective pain relief.
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Cite this: Another Abuse-Deterrent Opioid (Vantrela ER) Gets FDA Nod - Medscape - Jan 18, 2017.
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