The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
Following a successful end-of-Phase II meeting with the FDA, Lexicon Pharmaceuticals can now move forward with the late-stage development of its non-opioid analgesic pilavapadin, taking one step closer to what Jefferies estimates is a market opportunity that exceeds $1 billion.
Lexicon closed Wednesday’s trading session at $1.56, a 19% jump from its closing price of $1.31 on Tuesday.
“Pilavapadin’s development could be helped by regulatory tailwinds, supporting the use of non-opioid alternatives in chronic pain indications,” the Jefferies analysts wrote in a Wednesday note to investors, pointing specifically to a recently published draft guidance to help drugmakers develop non-opioid options for chronic pain.
Lexicon stands to gain from such regulatory flexibility, Jefferies said Wednesday. “The regulatory environment in chronic pain is improving, as the FDA is collaborating with sponsors on non-addictive alternatives,” they added. Lexicon is advancing pilavapadin for diabetic peripheral neuropathic pain (DPNP)—a market opportunity that could exceed $1 billion, according to Jefferies.
During the regulatory meeting, the FDA raised no issues regarding advancing pilavapadin into Phase III, Lexicon said in its news release. The company was also able to align with the agency on the pivotal design of the trial: two placebo-controlled studies that would run for 12 weeks, using a 10-mg daily oral dose. Change in average daily pain score was set as the program’s primary outcome.
At the meeting, the FDA also “did not require any unanticipated preclinical or clinical studies that would be expected to complicate or delay” the development of pilavapadin, Lexicon CEO Mike Exton said in a statement. If approved, pilavapadin would become the first non-opioid therapy for DPNP “in over two decades,” he added.
In March last year, Lexicon announced that the drug was unable to significantly ease pain in a Phase IIb study of DPNP as compared with placebo—results that at the time sank the biotech’s shares by 50%.
Still, Lexicon decided to push pilavapadin into late-stage development, pointing to its “enormous potential” in chronic pain. This decision was vindicated months later, in September, when a post-hoc data analysis found “nominally significant separation from placebo” in terms of pain improvement.
Jefferies also noted that beginning Phase III would be “contingent upon securing a BD partnership,” which the firm said could be helped by this positive FDA outcome.
