Voting 12 to 1 in support of the additional use, known in pharmaceuticals as an additional "indication," the panel of outside experts said the drug appears safe and could help those addicted to painkillers and heroin kick the habit. As expected, panelists expressed concern that the data is based on a single trial in Russia. The FDA doesn't have to follow the panel's recommendation, although it usually does. The final decision is expected on Oct. 12.
"The Advisory Committee meeting outcome today underscores the strength of the clinical data for Vivitrol and the need for new treatment options," said Alkermes CEO Richard Pops in a statement. "We believe that, if approved, Vivitrol would offer a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence."
Opioid abuse also represents a growing health problem in the U.S. According to the 2008 U.S. National Survey on Drug Use and Health, an estimated 1.3 million people aged 18 or older were opioid-dependent. The overall cost of prescription opioid abuse, including such factors as medical care, loss of productivity and criminal activity, has been estimated at $9.6 billion and the cost of heroin addiction has been estimated at $22 billion.
Vivitrol, a once-monthly injection, was approved as a treatment for alcohol dependence in 2006. But the biotech company found sales of the pricey drug disappointing, reaching only $20.2 million in fiscal 2010. The new use, if approved, could expand the drug's sales. According to Reuters, analyst Steve Yoo of Leerink Swann Research estimates sales could reach $125 million by 2015.
Trading in Alkermes was halted on the Nasdaq while the panel met Thursday, but when it resumed shares rose $1.03, or 7.2%, to $15.25 in after-hours trading, after closing Wednesday at $14.22. Year-to-date, shares up over 51%.