Duobril receives a CRL from the FDA
Valeant Pharmaceuticals (VRX) stock has been falling in June. Valeant’s division Ortho Dermatologics received a CRL (complete response letter) from the FDA on June 18 for its new drug application for Duobril, which treats plaque psoriasis.
Although the CRL didn’t mention any deficiencies in the clinical safety or efficacy, it raised questions related to the drug’s pharmacokinetic data. Duobril was expected to be one of the key drugs in Valeant’s product pipeline. The drug was expected to propel the company’s dermatology portfolio.
Valeant’s Siliq, which treats moderate to severe psoriasis, received FDA approval earlier. Duobril’s approval would have boosted the company’s position in the plaque psoriasis market.
On June 19, law firm Bronstein, Gewirtz, and Grossman announced an investigation. The investigation is focused on whether Valeant or its key personnel violated federal securities laws. On June 23, law firm Pomerantz announced another investigation. The investigation is focused on whether Valeant’s key personnel engaged in unlawful business practices or securities fraud.
After receiving the CRL for Duobril, Valeant stock fell 12.3% and closed at $23.5 on June 18. So far in June, the stock has fallen from a high of $26.8 on June 15 to $22.81 on June 27.
On June 26, Valeant’s division, Salix Pharmaceuticals, and US WorldMeds entered into an exclusive agreement to promote US WorlMed’s Lucemyra, which is the first and only medication on the market for mitigating opioid withdrawal symptoms to facilitate sudden discontinuation of opioids in adults.