Non-opioid pain medication moves forward to final phase of testing following supportive post-trial analysis, backed by pharmaceutical company Lexicon.
In a significant move for the chronic pain treatment landscape, Lexicon Pharmaceuticals has decided to advance its non-opioid pain medication, Pilavapadin, into Phase III development. This decision was based on the results of the Phase IIb PROGRESS study, which were announced by the company in March.
The FDA, in its ongoing efforts to encourage the development of non-addictive alternatives for chronic pain, last week released draft guidelines seeking to streamline this process. The FDA is open to accepting a 'single adequate and well-controlled' trial, plus confirmatory evidence, as the basis for a drug application. However, it's worth noting that these guidelines do not apply to the Phase III testing of Pilavapadin.
The Phase IIb PROGRESS study did not show a significant dose-response effect on pain scores compared to placebo. Nevertheless, a new post-hoc analysis of the trial, presented at the 2025 meeting of the European Associated for the Study of Diabetes, revealed a 'clinically meaningful' reduction in average daily pain after 11 weeks of treatment, particularly with the 10-mg daily dose of Pilavapadin. This dose was identified as the 'most clinically meaningful' by Lexicon Pharmaceuticals.
Interestingly, the new post-hoc analysis did not include the 20-mg arm of the trial, due to a lack of separation between this dose and placebo in terms of pain outcomes, as claimed by Lexicon Pharmaceuticals.
Analysts at Jefferies are optimistic about Pilavapadin's potential, with models estimating a '$1B+ blockbuster potential' for the drug. They also note that the regulatory environment for non-addictive options for chronic pain is improving. However, they caution that whether Pilavapadin can replicate pain reduction in Phase III is still an open question.
Jefferies anticipates pivotal studies for Pilavapadin to start by year-end or early next year, with topline findings expected between 2027 and 2028. The FDA is collaborating closely with sponsors who are developing non-addictive alternatives, and the agency encourages sponsors to look at 'potential biomarkers' that could qualify their investigational product for an expedited review program.
In conclusion, the advancement of Pilavapadin into Phase III development is a promising step towards the development of effective, non-addictive treatments for chronic pain. The results of upcoming studies will provide valuable insights into the drug's efficacy and potential as a game-changer in the field of pain management.
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