U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for Moderate-to-Severe Acute Pain

Viatris said the U.S. Food and Drug Administration has accepted its New Drug Application for fast-acting meloxicam, known as MR-107A-02, for the treatment of moderate-to-severe acute pain.

The company disclosed the filing acceptance on May 18, 2026. Viatris describes the product as an investigational non-opioid pain treatment and says the program remains on track for a regulatory decision in the second half of 2026.

What the filing means

FDA acceptance means the agency has completed an initial review of the application and will move it into the formal review process. It does not mean the drug has been approved.

Viatris said two pivotal Phase 3 studies of fast-acting meloxicam met their primary and secondary endpoints. The company is positioning the candidate as a potential option for acute pain management without the use of opioids.

Independent wire-service coverage republished the company announcement the same day, and company materials continue to say a decision is anticipated in H2 2026.

The next visible milestone for the program is the FDA review outcome later this year, unless the agency sets a separate public date for action.