Patients with severe pain that demands long-term, around-the-clock treatment now have a new medication to try. They will now be able to use Vantreal ER (hydrocodone bitartrate), which has gained the approval of the US Food and Drug Administration (FDA). The drug from Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) is suitable for daily management of acute pain when alternative treatment options are inadequate.
The product integrates novel abuse-deterrent technology. Its properties, however, are not expected to totally prevent oral, intranasal and intravenous abuse but they could reduce those rates.
Addressing Healio Family Medicine, Teva’s corporate communications director Doris Saltkill said, “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.”
The approval of the abuse-deterrent opioid treatment did not without a fight. Clinical abuse potential studies were carried out as well as its abuse potential in laboratory-based in vitro exploitation and extraction studies. Saltkill’s further explanation indicated that the approval of the tablets was for the doses of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
However, a word of caution was expressed, which clarified the risks associated with Vantrela ER. Addiction, abuse, and misuse can still lead to overdose and death according to a boxed warning. Other consequences include fatal respiratory depression.
But testing the efficacy of such drugs should extend beyond just pain
The FDA approval of Vantrela ER was triggered by a recommendation from an FDA advisory committee, which also advised on the labeling of oral, intranasal, and IV versions of the drug. The committee was satisfied with all the evidence presented regarding Vantrela ER’s effectiveness, safety, and tolerability.
However, a number of committee members did express the need to have the testing of the future drugs extended beyond pain analysis. While at this the FDA has launched a multiyear action plan, which will be based on new and existing policies and will help in tackling abuse and misuse of prescription opioids.
Meanwhile, Teva’s stock closed at $34.10 witnessing an increase of $0.35 or 1.04%.