FDA accepts Viatris drug application for fast-acting meloxicam pain treatment

The U.S. Food and Drug Administration has accepted Viatris Inc.'s (NASDAQ: VTRS) new drug application for MR-107A-02, a fast-acting meloxicam formulation intended to treat moderate-to-severe acute pain. The FDA assigned a PDUFA goal date of December 27, 2026.

The application is supported by data from two Phase 3 clinical trials that evaluated the drug following herniorrhaphy and bunionectomy surgeries. Both randomized, double-blind studies compared the investigational drug against placebo and included tramadol as an active control to validate the pain models.

In the herniorrhaphy trial, 579 patients were randomized, while the bunionectomy study included 410 patients. The primary endpoint measured pain intensity difference over 48 hours compared to placebo. Both studies also evaluated reduction in opioid rescue medication usage.

According to the company, fast-acting meloxicam met primary and secondary endpoints in both trials and demonstrated a safety profile consistent with the established mechanism of action for this class of drugs.

The drug candidate is a novel oral formulation of meloxicam, a non-steroidal anti-inflammatory drug, designed for more rapid dissolution and absorption than currently approved oral meloxicam products. Viatris submitted the application under the FDA's 505(b)(2) regulatory pathway.

"FDA's acceptance of the New Drug Application for investigational fast-acting meloxicam takes us one step closer to bringing a potential non-opioid first-line treatment option to patients with moderate-to-severe acute pain," said Philippe Martin, Viatris Chief R&D Officer.

Acute pain affects more than 80 million individuals in the United States annually, according to the company's press release.

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