JOHANNESBURG - Indivior shares surged the most in three months after a US Food and Drug Administration (FDA) panel backed the company’s treatment for addiction to opioids, the pain drugs linked to thousands of annual deaths.
Agency advisers voted 18 to 1 in support of the drug, known as RBP-6000, Indivior said. The FDA is poised to make a decision by the end of the month on the therapy, which is expected by analysts to generate $739million (R10.42billion) in annual sales in 2021.
Meanwhile, the regulatory panel is scheduled to review a competing therapy, from Camurus and Braeburn Pharmaceuticals yesterday. Access to the US market would come at a timely moment for Indivior, allowing the drug maker to tap the demand for new addiction treatments amid a rising tide of opioid overdose deaths that prompted President Donald Trump to declare a public health emergency last month.
FDA commissioner Scott Gottlieb has moved to encourage therapies for dependence and addiction using less harmful opioids such as buprenorphine, the active ingredient in Indivior’s sustained-release drug. Shares of the Slough, UK-based drugmaker rose almost 12percent to 415.60 pence (R77.54) at 9.16am in London, their biggest intraday gain since July 27. Indivior’s product is designed to treat opioid use disorder, the prolonged use of the painkillers for no legitimate medical purpose.