Tuesday, April 19, 2022

EU’s CHMP backs high-dose, once-monthly opioid dependence drug

The EU’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a new dose of Camurus’ prolonged-release injection opioid dependence treatment. 

Buvidal, which contains the active ingredient buprenorphine, is already available in the EU at a range of doses intended to be given either every week or every month via subcutaneous injection. The range of prefilled syringes gives physicians a long-lasting way of delivering buprenorphine, which is also available for daily to thrice-weekly dosing in the sublingual film Suboxone.

The positive CHMP decision puts Camurus on track to receive approval to sell a new, higher dose of its once-monthly formulation. The recommendation covers a 160-mg monthly dose. Currently, the highest monthly dose is 128 mg.

Having secured the recommendation, Camurus expects to get marketing authorization for the dose by the end of May. Camurus CEO Fredrik Tiberg hailed the recommendation as “an important step” in the push to provide people in the EU with the treatments they need.  

“Individualized dosing that meets patient’s medical needs is a cornerstone of opioid dependence treatment and we are pleased with this expected new addition to our wide range of weekly and monthly dosing options,” Tiberg said in a statement. 

Camurus developed the line of prolonged-release formulations using its FluidCrystal injection depot technology. FluidCrystal products feature an active ingredient dissolved in a lipid-based liquid. When the lipid solution interacts with fluids in the body, it morphs into a liquid crystalline gel that traps the active ingredient. The gel gradually releases the active ingredient as it degrades over days or weeks.  

Armed with data comparing Buvidal to Suboxone, Camurus won approval in the EU and Australia in 2018. Camurus’ U.S. partner Braeburn secured a tentative FDA approval late in 2018 but was kept off the market by an exclusivity period granted to Indivior’s Sublocade. In December, hopes of securing final approval in 2020 were dashed when the FDA found fault with a facility in a premarket inspection. 

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