Algia Pharma Gains FDA Support to Advance Novel Non-Opioid Pain Treatment Toward a Phase 2 Clinical Trial After IND-Enabling Studies With Indication Expanded to All Mild-to-Moderate Acute Pain

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BOCA RATON, Fla.--(BUSINESS WIRE)--Dec 15, 2025--

Algia Pharma, LLC (“Algia”) today announced the company has received support from the U.S. Food and Drug Administration (FDA) to advance AlgiaPak ® toward a Phase 2 clinical trial upon completion of Investigational New Drug (IND)-enabling studies. AlgiaPak is the company’s streamlined, multimodal pain formulation designed to treat all mild-to-moderate acute pain as effectively as opioids, without exposing patients to the risk of opioid addiction. The company has initiated IND-enabling studies with results anticipated in the second quarter of 2026.

“AlgiaPak combines multiple well-established, clinically proven medicines that act on non-opioid pain receptors to stop the transmission along the pain pathway into a single prescribing and dosing format intended to standardize hospital-grade multimodal pain control for outpatient use,” said David Steinberg, Pharm.D., J.D., co-founder and chief executive officer of Algia. “Initiating these IND-enabling studies for AlgiaPak is a major step forward in developing a safer, equally effective alternative to opioids to treat all mild-to-moderate acute pain. We look forward to working closely with the FDA to bring this new non-opioid treatment option to patients rapidly.”

“Multimodal pain control is already widely implemented in hospitals, creating a strong base of clinical familiarity that supports uptake in the outpatient market. Every component of AlgiaPak is already safe and proven effective,” said Hannah Thompson, M.D., co-founder and chief medical officer of Algia. “Our formulation is engineered for real-world usability, providing simpler dosing and adherence with a single prescription rather than multiple scripts and confusing intervals.”

Low-Risk Regulatory Pathway

The FDA recommended the 505(b)(2) regulatory pathway for AlgiaPak. The agency also recommended reducing the study duration from seven to three days. Algia intends to file for expedited review.

“We are encouraged by the FDA’s detailed and positive feedback supporting a low-risk, accelerated development path,” said Joseph Loskove, M.D., co-founder and chief operating officer of Algia. “We are especially pleased the FDA broadened our initial indication beyond perioperative pain to all mild-to-moderate acute pain, dramatically expanding clinical and commercial potential.”

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.

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.

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KEYWORD: FLORIDA UNITED STATES NORTH AMERICA

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SOURCE: Algia Pharma, LLC

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PUB: 12/15/2025 07:30 AM/DISC: 12/15/2025 07:30 AM

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