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

Viatris (Nasdaq: VTRS) announced that the U.S. FDA has accepted its New Drug Application for MR-107A-02 fast-acting meloxicam, a non-opioid treatment for moderate-to-severe acute pain.

Rhea-AI Summary

Viatris (Nasdaq: VTRS) announced that the U.S. FDA has accepted its New Drug Application for MR-107A-02 fast-acting meloxicam, a non-opioid treatment for moderate-to-severe acute pain. The FDA set a PDUFA goal date of Dec. 27, 2026.

The NDA is backed by two Phase 3 randomized, double-blind, placebo- and active-controlled trials in herniorrhaphy and bunionectomy patients. Fast-acting meloxicam met primary and secondary endpoints, reduced opioid use, and showed a safety profile consistent with its mechanism of action.

Positive

• FDA acceptance of NDA for fast-acting meloxicam with Dec. 27, 2026 PDUFA date
• Two Phase 3 trials met primary and secondary efficacy endpoints versus placebo
• Clinical program showed significant reduction in opioid usage in acute pain setting
• Safety profile consistent with well-characterized mechanism of action
• Phase 3 program included 579 herniorrhaphy and 410 bunionectomy subjects

Negative

• None.

Argus May 18 session

+0.12% close to close Open Argus

Details

News Market Reaction – VTRS

On May 18, the day this news came out, VTRS closed 0.12% above the previous close.

Data tracked by StockTitan Argus for the May 18 session.

Market Context

This announcement details FDA acceptance of Viatris’ NDA for fast-acting meloxicam, with a PDUFA goa...

Analysis

This announcement details FDA acceptance of Viatris’ NDA for fast-acting meloxicam, with a PDUFA goal date of Dec. 27, 2026, supported by two randomized Phase 3 trials in post-surgical acute pain. The data showed primary and secondary endpoints met and reduced opioid use, adding another late-stage asset alongside MR‑141, MR‑142 and XULANE LO. Investors may watch upcoming regulatory milestones, additional data presentations, and how this non-opioid option fits into the large U.S. acute-pain market affecting over 80 million people.

Key Figures

PDUFA goal date: Dec. 27, 2026 Acute pain prevalence: more than 80 million individuals Opioid comparator dose: tramadol 50 mg q6h +4 more

PDUFA goal date

Dec. 27, 2026

FDA review timeline for fast-acting meloxicam NDA

Acute pain prevalence

more than 80 million individuals

U.S. patients affected by acute pain each year

Opioid comparator dose

tramadol 50 mg q6h

Opioid arm to confirm pain model sensitivity

Primary endpoint window

0–48 hours

SPID0-48h pain intensity difference vs placebo

Herniorrhaphy subjects

579 patients

Randomized in NCT06215859 Phase 3 trial

Bunionectomy subjects

410 patients

Randomized in NCT06215820 Phase 3 trial

Eligible age

18 years or older

Post-operative patients in both Phase 3 trials

Previous Clinical trial Reports

5 past events · Latest: Feb 25

Same Type 5 events

1. Feb 25

   sNDA accepted

   24h Move

   +0.1%

   FDA accepted sNDA for MR-141 in presbyopia with PDUFA date set.

2. Jul 18

   Trial setback

   24h Move

   -4.2%

   Phase 3 MR-139 blepharitis study failed primary endpoint of debris resolution.

3. Jun 26

   Positive Phase 3 data

   24h Move

   +2.6%

   VEGA-3 Phase 3 trial of MR-141 in presbyopia met primary and secondary endpoints.

4. Jun 02

   Positive Phase 3 data

   24h Move

   -1.1%

   LYNX-2 Phase 3 trial of MR-142 met primary endpoint under FDA SPA.

5. May 08

   Positive Phase 3 data

   24h Move

   +5.7%

   Phase 3 results for XULANE LO contraceptive patch showed favorable efficacy and safety.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pdufa, new drug application (nda), non-opioid, phase 3, +4 more

8 terms

pdufa regulatory

"The FDA has assigned a PDUFA goal date of Dec. 27, 2026."

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

new drug application (nda) regulatory

"FDA has accepted for review the New Drug Application (NDA) for MR-107A-02"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

non-opioid medical

"MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment"

Non-opioid describes medicines or therapies that relieve pain or treat conditions without using opioid drugs, which act on the brain’s opioid receptors. For investors, non-opioid products matter because they often face fewer addiction and regulatory risks, may win faster approvals or wider adoption, and can open new markets much like a different tool in a toolbox that solves the same problem without the same safety concerns.

phase 3 medical

"The NDA is supported by data from the Phase 3 program which was presented"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized, double-blind medical

"two randomized, double-blind, placebo-(double-dummy) and active-controlled trials"

A randomized, double-blind study is a clinical trial design where participants are assigned by chance to different groups (for example, a new treatment or a control) and neither the participants nor the researchers know who is in which group. This setup reduces conscious or unconscious bias—think of it like a blind taste test—so results are more reliable and investors can have greater confidence that reported effects reflect the treatment itself rather than expectations or selective reporting.

double-dummy medical

"randomized, double-blind, placebo-(double-dummy) and active-controlled trials"

A double-dummy trial is a clinical study design that keeps patients and staff blind when comparing two treatments that look or are given differently by giving every participant both a real version of one treatment and a matching placebo of the other. This prevents bias in judging which option works or is safer—like testing two phone models while everyone uses identical shells—so results are more reliable for regulatory decisions, market forecasts and investor risk assessment.

active-controlled medical

"placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy"

An active-controlled study is a trial in which the new treatment is compared against an existing, approved treatment instead of a placebo. For investors, this matters because results show how the new product stacks up against the current standard—like testing a new phone by comparing it to a popular model rather than to no phone—so positive results can indicate real competitive advantage and clearer market value.

bunionectomy medical

"one following bunionectomy surgery (NCT06215820).Both Phase 3 trials evaluated"

A bunionectomy is a surgical procedure that removes a bony bump at the base of the big toe and realigns the toe joint to relieve pain and restore normal foot function, like repairing a misaligned foundation in a house. Investors care because procedure volume, costs, device sales, insurance reimbursement and new surgical techniques can affect hospitals, device makers and insurers’ revenues and profitability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

FDA PDUFA Goal Date Set for Dec. 27, 2026

PITTSBURGH, May 18, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026. Acute pain affects more than 80 million individuals in the United States each year, where opioids remain a commonly used treatment option.^1,2

"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, which will help address an important public health need in the United States," said Philippe Martin, Viatris Chief R&D Officer. "Fast-acting meloxicam is one of several value-added medicines in our pipeline. We are proud of the strength of the clinical profile supporting this program, which includes a fast speed of onset of action, strong and sustained analgesic efficacy with a significant reduction in opioid usage, together with an established mechanism of action and well characterized safety profile."

The NDA is supported by data from the Phase 3 program which was presented at PAINWeek 2025. The Phase 3 program consisted of two randomized, double-blind, placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy surgery (NCT06215859) and one following bunionectomy surgery (NCT06215820).

Both Phase 3 trials evaluated the efficacy and safety of fast-acting meloxicam versus placebo and included an opioid arm (tramadol 50mg q6h) to confirm the sensitivity of the pain model. The primary endpoint in both trials was defined by the Sum of Pain Intensity Difference (SPID) based on the Numeric Rating Scale measured over 0-48 hours (SPID_0-48h) versus placebo. Both trials evaluated the reduction in opioid usage that was defined by number of mean doses of opioid rescue medication and proportion of opioid-free patients over the combined in- and out-patient treatment phases. In both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action.

Viatris is pursuing several value-added medicines, including fast-acting meloxicam, to drive high value products through life cycle optimization including new formulations, delivery technologies and indications.

Phase 3 Trial Design for Herniorrhaphy (NCT06215859) and Bunionectomy (NCT06215820) 
Post-operative herniorrhaphy and bunionectomy patients aged 18 or older who experienced moderate-to-severe acute pain following surgery were eligible to participate in the trials, NCT06215859 and NCT06215820, respectively. 579 herniorrhaphy subjects and 410 bunionectomy subjects were randomized and received doses of either MR-107A-02, tramadol or placebo during the inpatient phase (0-48h). During the outpatient phase, subjects continued to receive the study drug. Subjects randomized to receive tramadol during the inpatient phase received placebo in the outpatient phase.

About Acute Pain
Acute pain is defined as pain of sudden onset associated with a known cause—such as surgery, trauma, or acute illness—and is typically self-limiting, resolving within 30 days to three months. It affects more than 80 million individuals in the United States. each year and is a primary driver of emergency department visits and postoperative morbidity. Clinically, it contributes to delayed recovery, impaired physical function, poor sleep, and reduced quality of life. Economically, the burden of acute pain is substantial, including both direct medical expenses and indirect costs such as lost productivity and disability. Societally, inadequate pain control affects patient satisfaction and rehabilitation outcomes, contributes to opioid prescribing and potential misuse. Despite the widespread impact, more than half of surgical patients report inadequate pain relief, reflecting a significant unmet need for effective, non-opioid treatment options with rapid onset and favorable safety profiles.

About Fast-Acting Meloxicam
Fast-acting meloxicam (MR-107A-02) is an investigational, novel fast-acting oral formulation of meloxicam being developed by Viatris for the treatment of moderate-to-severe acute pain. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID), and this formulation was designed to enable more rapid dissolution and absorption than currently approved oral meloxicam products. Viatris has reported positive results from two pivotal Phase 3 studies of MR-107A-02 in acute post-surgical pain models following bunionectomy and herniorrhaphy. MR-107A-02 has been submitted to the U.S. Food and Drug Administration for review under the 505(b)(2) regulatory pathway and has not been approved by any regulatory authority.

References

1. Lopez et al. "A real-world database analysis of the prevalence of pain medication use in the United States." Pain Reports, vol. 11, 2026, e1396.
2. Centers for Disease Control and Prevention. About Prescription Opioids. Accessed April 2026.

About Viatris 
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that FDA has accepted for review the NDA for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain; the FDA has assigned a PDUFA goal date of Dec. 27, 2026; FDA's acceptance of the NDA 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, which will help address an important public health need in the United States; fast-acting meloxicam is one of several value-added medicines in our pipeline; we are proud of the strength of the clinical profile supporting this program, which includes a fast speed of onset of action, strong and sustained analgesic efficacy with a significant reduction in opioid usage, together with an established mechanism of action and well characterized safety profile; information about clinical trials; in both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action; Viatris is pursuing several value-added medicines, including fast-acting meloxicam, to drive high value products through life cycle optimization including new formulations, delivery technologies and indications. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/us-fda-accepts-viatris-new-drug-application-for-fast-acting-meloxicam-for-the-treatment-of-moderate-to-severe-acute-pain-302774276.html

SOURCE Viatris Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Viatris (VTRS) announce about its fast-acting meloxicam NDA in May 2026?

Viatris announced that the U.S. FDA accepted its New Drug Application for fast-acting meloxicam to treat moderate-to-severe acute pain. According to Viatris, this investigational non-opioid candidate aims to provide a potential first-line option in a setting where opioids remain widely used.

What is the FDA PDUFA goal date for Viatris (VTRS) fast-acting meloxicam?

The FDA set a PDUFA goal date of December 27, 2026 for the fast-acting meloxicam NDA. According to Viatris, this date represents the target timing for the FDA’s review decision on the proposed treatment for moderate-to-severe acute pain.

What Phase 3 clinical trial results support Viatris (VTRS) fast-acting meloxicam NDA?

The NDA is supported by two Phase 3 randomized, double-blind, placebo- and active-controlled trials in herniorrhaphy and bunionectomy patients. According to Viatris, fast-acting meloxicam met primary and secondary endpoints and showed strong, sustained analgesic efficacy with a significant reduction in opioid usage.

How did fast-acting meloxicam affect opioid use in Viatris (VTRS) Phase 3 trials?

Fast-acting meloxicam was associated with a significant reduction in opioid usage in both Phase 3 studies. According to Viatris, trials measured mean doses of opioid rescue medication and the proportion of opioid-free patients across inpatient and outpatient phases, favoring fast-acting meloxicam.

What was the design of the Phase 3 trials for Viatris (VTRS) fast-acting meloxicam?

The Phase 3 program included two randomized, double-blind, placebo- and active-controlled trials after herniorrhaphy and bunionectomy surgery. According to Viatris, 579 herniorrhaphy and 410 bunionectomy subjects received fast-acting meloxicam, tramadol, or placebo, with pain intensity measured over 0–48 hours.

What safety profile did Viatris (VTRS) report for fast-acting meloxicam in Phase 3?

Fast-acting meloxicam demonstrated a safety profile consistent with the well-characterized safety profile of its mechanism of action. According to Viatris, this safety observation came from both Phase 3 trials evaluating efficacy and safety versus placebo and an opioid comparator in acute postoperative pain.