Ouch: Cipher Maintains Phase III Trial Failure Of Tramadol Will Not Impact NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Ontario drug maker may have to contend with two other competitors in the synthetic opioid space.
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Cipher Pharmaceuticals maintains that its user fee date for the pain medication CIP-tramadol ER should not be impacted by a Phase III trial that failed to achieve statistical significance. The Phase III efficacy trial, the fourth such study Cipher has conducted, demonstrated reduction in pain from baseline, the primary endpoint, but the results were marred by a higher than anticipated placebo effect, the Ontario drug maker said Sept. 11. CEO Larry Andrews told "The Pink Sheet" DAILY that the fourth study was never intended to be part of the FDA submission package, which has a user fee date of May 1, 2007. Cipher's July 1 NDA submission contained data from the other three efficacy trials, as well as two Phase III long-term safety studies and six pharmacokinetic trials (1 (Also see "CIP-Tramadol Has April 2007 User Fee Date" - Pink Sheet, 29 Jun, 2006.)). The company announced FDA's acceptance of the package Sept. 5 and has been informed by the agency that the clinical data submitted is sufficient to make a decision. Even if CIP-tramadol ER gains FDA approval next year, it will likely be the third tramadol ER product to hit the U.S. market. Fellow Canadian pharmaceutical Biovail already markets J&J subsidiary Ortho-McNeil's Ultram under a promotional partnership (2 (Also see "Biovail To Market Tramadol Under Ortho’s Ultram Brand" - Pink Sheet, 4 Nov, 2005.)). Quebec-based Labopharm could have the second extended-release tramadol on the market. The company's once-daily tramadol, which would be marketed by Purdue Pharma, has an FDA user fee date of Sept. 28 (3 (Also see "Labopharm To Pursue FDA Approval For Once-Daily Tramadol" - Pink Sheet, 4 Nov, 2005.)). Cipher's business plan is to outlicense the product to a U.S. partner to handle marketing, Andrews said. The exec said one way Cipher's product differs from the other two tramadol extended-release products is its absorption profile. According to the exec, Cipher's tramadol has an onset of action within one hour, compared to within two hours for Labopharm's product and four to five hours for Biovail's product. The market for tramadol-ER products is expected to climb to $1 bil. annually, according to Andrews, who believes that there will be room for CIP-tramadol-ER in the market even with two other competitors. Tramadol is a synthetic opioid used to treat moderate to moderately severe pain. Andrews said tramadol has advantages over traditional opioids because there is less risk of dependency or addiction, as well as a favorable side effect profile compared to COX-2s. He added that there is a space in the market for tramadol that would fit between NSAIDs and opioids. Shares of Cipher dropped more than 26% at the close of business on the Toronto Stock Exchange Sept. 11. - Jonathan Block ([email protected]) |