Algia Pharma completes investigational drug toxicology study for non-opioid acute pain regimen AlgiaPak

AlgiaPak, an investigational multimodal regimen intended to treat mild-to-moderate acute pain without opioids, was tolerated in a preclinical toxicology study that the company says clears the way for an Investigational New Drug (IND) application to the FDA, Algia Pharma announced in a news release.

The IND-enabling study, conducted under Good Laboratory Practice (GLP) standards, found AlgiaPak was tolerated at the dose level tested, with no adverse gross pathological or histopathological findings in the gastrointestinal tract, according to the Boca Raton, Fla.-based company. The release did not disclose the dose evaluated or other study details.

“Completing our IND-enabling toxicology study represents a crucial milestone in the development of AlgiaPak. This progress comes as we seek funding to advance the AlgiaPak clinical program toward a Phase 2a trial,” David Steinberg, Pharm.D., J.D., co-founder and CEO of Algia Pharma, said in the news release.

When AlgiaPak could enter Phase 2 clinical trials

Algia expects to submit its IND application by the end of 2026. Pending regulatory clearance, the company plans to begin a Phase 2a randomized, double-blind trial in the first quarter of 2027 evaluating the efficacy and safety of AlgiaPak in patients with mild-to-moderate acute pain following bunionectomy.

The company previously said the FDA supported advancing AlgiaPak to a Phase 2 trial once IND-enabling studies were complete. According to Algia, the agency recommended the 505(b)(2) regulatory pathway, which allows a sponsor to rely in part on existing data for previously approved drugs, and recommended shortening the Phase 2 study duration from seven days to three. The FDA also broadened the initial indication beyond perioperative pain to all mild-to-moderate acute pain, the company said. Algia intends to file for Fast Track review.

How AlgiaPak is designed for outpatient pain control

AlgiaPak is a combination of several established medicines that act on non-opioid pain receptors in a single prescribing and dosing format. The goal, according to the company, is to standardize the type of multimodal pain control used in hospitals for outpatient settings, giving patients one prescription rather than several with complex dosing schedules. The release did not name the individual medicines in the regimen.

Algia holds three issued U.S. patents, with additional filings underway in the United States and Europe. The company said it is developing a pricing strategy intended to be competitive with opioid prescriptions.

Why non-opioid acute pain options matter for payers

Algia framed the program around the continuing toll of opioid misuse. The company cited more than 100,000 drug overdose deaths each year in the United States and research showing that up to 10% of patients exposed to opioids under clinical care become addicted. U.S. clinicians wrote nearly 142 million opioid pain prescriptions in 2020, the company noted, even though multimodal non-opioid strategies have been shown to provide comparable pain control for mild-to-moderate pain. Those hospital regimens have not been standardized for outpatient use, which the company said limits access once patients are discharged.

The non-opioid acute pain market is expanding. In early 2025, the FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine) for adults with moderate to acute pain.

Federal payment policy has also shifted toward non-opioid options. Under the NOPAIN Act, Medicare provides separate payment for qualifying non-opioid pain treatments in hospital outpatient departments and ambulatory surgery centers from 2025 through 2027.

“Expanding non-opioid treatment options is essential to helping patients manage acute pain while reducing reliance on opioids,” Steinberg said. “We are actively finalizing our regulatory dossier and anticipate submitting the IND application for AlgiaPak to the FDA in the coming months.”