FDA approves Vantrela ER for severe pain
The FDA has approved Vantrela ER, an extended release tablet, for patients with severe pain that necessitates long-term, around-the-clock treatment, according to a press release from its manufacturer.
Teva Pharmaceuticals also stated that the prescribing information will include details on the drug’s abuse-deterrent properties, which may reduce IV, intranasal and oral misuse of the drug.
“The abuse-deterrent properties of Vantrela ER are created through a hydrocodone-polymer mix which is coated with a polymeric film and then matrixed for compression of the granules to form a tablet,” Doris Saltkill, director, corporate communications, Teva Pharmaceuticals, told Healio Family Medicine. “[This] provides resistance against common physical manipulation and chemical extraction techniques.”
The company’s chief scientific officer said developing and utilizing the technology was an important step to take.
“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward,” Michael Hayden, MD, PhD, said in a press release. “We are committed to furthering responsible pain management.”
According to the release, adverse events associated with Vantrela ER (hydrocodone bitartrate, Teva Pharmaceuticals) include anxiety, insomnia, diarrhea, dry mouth, fatigue, pruritus, dizziness, vomiting, somnolence, headache, constipation and nausea. Teva stated these occurred in more than 2% of patients during placebo-controlled trials.
Saltkill said the tablets were approved in doses of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, and laid out the possible plans for its availability.
“We are evaluating various scenarios to maximize the value of Vantrela ER and our overall portfolio as part of our 2017 business plan,” she said.
The FDA’s action regarding Vantrela comes nearly 8 months after its advisory committee recommended approval and continues a trend of FDA decisions regarding pain relief agents.
Just last week, the FDA approved Arymo ER (morphine sulfate, Egalet) for patients with severe chronic pain, and last August, the agency approved Pfizer’s Troxyca ER (oxycodone hydrochloride/naltrexone hydrochloride), also for the same population.
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Disclosures: Hayden and Saltkill work for Teva Pharmaceuticals.