Algia Pharma, LLC announced that it has received FDA support to advance its non-opioid pain treatment, AlgiaPak, toward a Phase 2 clinical trial following completion of Investigational New Drug enabling studies. AlgiaPak is a multimodal pain formulation designed to manage all mild-to-moderate acute pain effectively while avoiding the risks associated with opioid use. The company has initiated IND-enabling studies and expects results by the second quarter of 2026.
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David Steinberg, Pharm.D., J.D., co-founder and chief executive officer of Algia, explained that AlgiaPak combines several clinically proven medications targeting non-opioid pain pathways into a single formulation. He said the product is designed to standardize hospital-grade multimodal pain control for outpatient use, simplify prescribing, and offer a safer alternative to opioids. Steinberg emphasized that beginning these studies is a critical step in developing an accessible, non-addictive pain treatment and that Algia will work closely with the FDA to bring the therapy to patients quickly.
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Hannah Thompson, M.D., co-founder and chief medical officer of Algia, added that multimodal pain management is already widely used in hospitals and has strong clinical acceptance, making it easier to transition to outpatient care. She noted that each component of AlgiaPak is safe and proven, and the formulation simplifies adherence by consolidating multiple medications into a single prescription with standardized dosing.
The FDA recommended that Algia pursue the 505(b)(2) regulatory pathway and suggested shortening the study duration from seven to three days. Joseph Loskove, M.D., co-founder and chief operating officer of Algia, said the FDA’s feedback supports a low-risk and accelerated development process. He highlighted that the FDA also expanded the initial indication from perioperative pain to all mild-to-moderate acute pain, significantly increasing the clinical and commercial potential of AlgiaPak.
Algia has secured three U.S. patents with additional applications pending in the United States and Europe. The company is also developing a pricing strategy intended to be competitive with current opioid prescriptions.
The need for safe, effective non-opioid pain treatments is urgent. Globally, over 500,000 people die from drug overdoses each year, including more than 100,000 in the United States. Studies show that up to ten percent of patients exposed to opioids in clinical care may develop an addiction. In 2020 alone, nearly 142 million opioid prescriptions were written in the United States, despite evidence that multimodal non-opioid strategies can provide equivalent pain relief for mild-to-moderate pain. AlgiaPak aims to bring hospital-grade multimodal pain management to outpatient settings, improving patient access and safety while reducing reliance on opioids.
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