Algia Pharma Reports Positive Topline Results From IND-Enabling Study of AlgiaPak® for Non-Opioid Treatment of Mild-to-Moderate Acute Pain

GLP toxicology evaluations successfully completed, establishing a clear path toward clinical development directly to Phase 2

Algia Pharma’s novel multimodal pain regimen, AlgiaPak®, designed to deliver opioid-level pain relief without addiction risk

IND application submission planned by end of 2026 with Phase 2 clinical trial aimed to initiate first quarter 2027

BOCA RATON, Fla.--(BUSINESS WIRE)--Algia Pharma, LLC (“Algia”) today announced the successful completion of its Investigational New Drug (IND)-enabling preclinical toxicology study for AlgiaPak®. AlgiaPak is a hospital-grade multimodal pain regimen designed to treat all mild-to-moderate acute pain as effectively as opioids, without exposing patients to the risk of opioid addiction.

Results from the study, conducted in full compliance with Good Laboratory Practice (GLP) standards, demonstrated that AlgiaPak was tolerated at the dose level tested with no adverse gross pathological or histopathological findings in the gastrointestinal (GI) tract.

“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,” said David Steinberg, Pharm.D., J.D., co-founder and chief executive officer of Algia Pharma. “Expanding non-opioid treatment options is essential to helping patients manage acute pain while reducing reliance on opioids. We are actively finalizing our regulatory dossier and anticipate submitting the IND application for AlgiaPak to the FDA in the coming months.”

Backed by these positive results, Algia is rapidly shifting focus toward clinical operational readiness. The company expects to submit its IND application to the FDA by the end of 2026. Upon regulatory clearance, a Phase 2a randomized double-blind clinical trial evaluating the efficacy and safety of AlgiaPak in patients with mild-to-moderate acute pain following bunionectomy is anticipated to initiate in the first quarter of 2027.

In December 2025, the company announced it received support from the U.S. Food and Drug Administration (FDA) to advance AlgiaPak toward a Phase 2 clinical trial upon completion of IND-enabling studies. The FDA recommended the 505(b)(2) regulatory pathway for AlgiaPak. The Agency also recommended reducing the Phase 2 study duration from seven to three days. Algia intends to file for Fast Track review. Additionally, the FDA broadened the initial indication for AlgiaPak beyond perioperative pain to all mild-to-moderate acute pain, dramatically expanding clinical and commercial potential.

AlgiaPak combines multiple well-established, clinically proven medicines that target non-opioid pain receptors into a single prescribing and dosing format intended to standardize hospital-grade multimodal pain control for outpatient settings. The formulation of AlgiaPak is designed for real-world application, enhancing ease of dosing and adherence by offering a single prescription instead of multiple prescriptions with complex dosing schedules.

Algia has secured three issued U.S. patents, with additional filings underway in the U.S. and Europe. The company is developing a pricing strategy designed to be competitive with opioid prescriptions creating the most accessible non-opioid pain drug on the market.

Large and Urgent Unmet Need

More than 500,000 people die from drug overdoses globally each year, including more than 100,000 in the United States. Research shows that up to 10 percent of patients exposed to opioids under clinical care become addicted. U.S. clinicians wrote nearly 142 million opioid pain prescriptions in 2020 alone – even though multimodal non-opioid pain strategies have been clinically validated to achieve equivalent pain control for mild-to-moderate pain. However, hospital-grade multimodal regimens have not been standardized for outpatient use, limiting access and adoption when patients leave the hospital setting.

About Algia Pharma

Algia Pharma is a pharmaceutical company dedicated to reducing opioid exposure across the healthcare system by making hospital-grade multimodal pain control available, practical, and affordable in everyday outpatient care. Algia is developing the AlgiaPak^®, a simple, multimodal pain regimen designed to treat mild-to-moderate acute pain as effectively as opioids without addiction risk. The company was founded by two anesthesiologists, Hannah Thompson, M.D., and Joseph Loskove, M.D., and pharmacist David Steinberg, Pharm.D., J.D., who together have decades of front-line experience in pain management. For more information, please visit https://algiapharma.com or follow us on LinkedIn.