Indivior (INVVY) surged in Wednesday morning trading after an advisory group at the Food and Drugs Administration recommended the company's treatment for opioid addiction be approved.
Indivior shares jumped to the top of the FTSE 250, gaining 11% in the first hour of trading, changing hands at 411.80 pence, extending a 4.5% three-month gain.
The company looks set to benefit from President Donald Trump's crackdown on the opioid crisis, after the the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA on Oct. 31 voted in favor of recommending Indivior's RBP-6000 treatment of opioid use disorder (OUD).
President Trump declared a national emergency over opioid addiction earlier this year. The U.S. Centers for Disease Control and Prevention estimate that around 2.6 million people are addicted to opium-derived drugs.
"The Advisory Committees' favorable recommendation of RBP-6000 moves us one step closer to potentially bringing this once-monthly injectable buprenorphine treatment option to patients struggling with opioid use disorder," said Indivior CEO Shaun Thaxter said in a statement. "We are committed to pioneering new options for patients living with this chronic, yet treatable disease to help address the nation's growing opioid epidemic."
RBP-6000 is used as part of a complete treatment plan to include counseling and psychosocial support.
Indivior said the FDA will consider the Advisory Committees' non-binding recommendation in its review of the New Drug Application for RBP-6000 that was submitted on May 30, 2017.
In September, Indivior warned of competition from generics to its key products after the U.S. District Court in Delaware has found that claims of a proposed generic version of Indivior's opioid addiction treatment by Dr. Reddy's does not infringe patents.
The maker of Suboxone said that if a generic of the product were to come to market "it could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market."
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