October 21, 2021

New Drugs, Generics, and a COVID-19 Treatment Update

Over the last month, several new drug developments have occurred which have the potential to impact workers’ comp. A new migraine drug was approved, while several first-time generics were approved as well. Additionally, a new COVID-19 therapy in Phase 3 trials is gaining attention.

Qulipta Approved for Migraine Prevention

In late September, Qulipta (atogepant) tablets for oral use were approved by the FDA for the preventive treatment of episodic migraines. According to the drug label, these once daily tablets are available in 10 mg, 30 mg, or 60 mg doses. Adverse reactions include nausea, constipation, and fatigue.

Generic Approvals

The following medications have received their first generic approvals:

  • Belbuca (buprenorphine) buccal film for the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate
  • Duexis (ibuprofen and famotidine) tablets for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers
  • Xeljanz XR (tofacitinib) extended-release tablets for the treatment of moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, or ulcerative colitis. Previously, a Xeljanz generic was approved, but that approval was for the original Xeljanz. This new approval is for the extended-release version

Molnupiravir Gains Attention as Potential COVID-19 Treatment

Results from a Phase 3 clinical trial found that molnupiravir, an investigational oral antiviral designed to inhibit the replication of the virus causing COVID-19, reduced the chance of hospitalization or death for patients at risk of severe disease by 50%.

The randomized, placebo-controlled, double-blind, multi-site study involved 775 non-hospitalized patients with mild-to-moderate COVID-19 and at least one risk factor associated with poor disease outcome. Approximately 14.1% of patients who received placebo were either hospitalized or died following 29 days, compared with 7.3% among patients who received molnupiravir. No deaths were reported by day 29 in the molnupiravir group, while eight deaths were reported in the placebo group.

Molnupiravir demonstrated consistent efficacy across all known viral variants, including Gamma, Delta, and Mu. Merck, the drug manufacturer, plans to submit an application for an emergency use authorization (EUA) as soon as possible.

If eventually approved by the FDA, this drug would be the first oral antiviral medication for COVID-19.

For all of the latest updates on FDA drug approvals impacting workers’ comp, check out our interactive web tool, MedMonitor.

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