The Federal Pain Research Strategy identified an urgent need to reduce reliance on prescription opioid medications through the development of new, non-opioid treatments for pain. The NIH HEAL Initiative was designed to accelerate the development of new drugs for this need. Over 25 million Americans have chronic pain and take opioids for pain control.
"We are thrilled that the NIH will investigate Profervia®'s analgesic effects in multiple validated pain models," said Andrew Sternlicht, M.D., CEO and Founder of Aisa Pharma. "Early data from our current Phase 2 study in SSc-RP patients reported impressive reductions in pain versus placebo."
The PSPP program will assess Profervia® in in-vitro assays and preclinical animal models of human pain conditions. It will assess pharmacokinetics, safety, and efficacy. The work is performed at the NIH-NINDS, with rights retained by Aisa Pharma.
Profervia® is a novel form of cilnidipine, a fourth-generation calcium channel blocker(CCB). Cilnidipine is approved in select Asian countries for hypertension with decades of safety data. Cilnidipine increases blood flow to peripheral tissues and further improves function in the heart, kidney and vasculature. Cardiac, renal and vascular disease contribute to morbidity and mortality in patients with SSc. Thus, cilnidipine may improve SSc-RP, and the underlying disease. In robust studies of hypertension treatment, cilnidipine was better tolerated than US-approved CCBs, which are used off-label for Raynaud's. Unlike other approved CCBs, cilnidipine also targets receptors that have a role in certain painful conditions.
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