Idorsia Requests DEA Lift Controlled Substance Restrictions On Dual Orexin Receptor Antagonists For Insomnia
Schedule IV classification for Idorsia’s Quviviq, along with Merck & Co’s Belsomra and Eisai’s Dayvigo, distorts the drug class’ benefit-risk profile relative to other insomnia treatments, which are prioritized for prescribing but carry higher risk of abuse and other adverse events, company says.
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Idorsia has a serious cashflow problem because of major R&D and drug launch commitments, but is banking on its blockbuster bets coming good, including two potential first-in-class cardiovascular drugs.
The company’s Quviviq launch has fallen short of early expectations, but Idorsia believes a patient approach will pay off for the blockbuster-tipped insomnia treatment.
Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker