Indivior's monthly opioid treatment recommended for FDA approval
Indivior
1,435.00p
16:54 03/05/24
Indivior may soon give Donald Trump a new weapon is his campaign against the opioid crisis after the London-listed company's long-lasting treatment of opioid use disorder was recommended for approval by the US drug regulator's advisory body.
FTSE 250
20,164.54
17:00 03/05/24
FTSE 350
4,515.50
16:54 03/05/24
FTSE All-Share
4,469.09
17:14 03/05/24
Pharmaceuticals & Biotechnology
23,112.61
16:54 03/05/24
Overnight the US Food & Drug Administration's drugs advisory committee and drug safety and risk management advisory committee voted 18 to 1 to recommend approval of Indivior's RBP-6000, which was largely as expected.
Indivior, which has worked closely with the FDA on the final stages of development of RBP-6000, has produced a once-monthly injectable buprenorphine formulation using the 'Atrigel' delivery system to treat adults with moderate-to-severe opioid use disorder, as part of a complete treatment plan to include counselling and psycho-social support.
"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 chief executive Shaun Thaxter.
"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."
The FDA will consider the advisory committees' non-binding recommendation in its review of the new drug application for RBP-6000 that Invidior submitted in May.
The FDA has set a deadline of 30 November.
Expecting approval to be granted, analysts at RBC Capital Markets earlier conducted a survey among 77 US physicians and calculated the product could take a circa-39% patient share quickly and sees peak sales of $1.4bn in the US as possible.