Clarinex Clinical, Safety Characteristics Support OTC Use – WellPoint
This article was originally published in The Tan Sheet
Executive Summary
The similar safety and efficacy profile of Schering-Plough's follow-on drug Clarinex (desloratadine) to other second-generation antihistamines makes it appropriate for OTC availability, WellPoint Health Networks asserts in an April 15 petition to FDA
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The similar safety and efficacy profile of Schering-Plough's follow-on drug Clarinex (desloratadine) to other second-generation antihistamines makes it appropriate for OTC availability, WellPoint Health Networks asserts in an April 15 petition to FDA. Chief Pharmacy Officer Robert Seidman notes that based on the available data, "there are no significant clinical or safety differentiating factors between desloratadine and the other non-sedating antihistamines that would preclude OTC status for" Clarinex, requesting FDA "expedite an OTC approval" for the allergy drug. The petition comes exactly a week before three FDA advisory committees will review Schering's three supplemental NDAs to switch Claritin (loratadine) OTC; WellPoint also led the push to switch the non-sedating antihistamine through a petition filed in 1998. In its most recent filing, WellPoint cites four multiple-dose studies submitted by Schering as part of the FDA approval process for Clarinex. One study failed to demonstrate a difference between desloratadine and placebo, the petition notes, and "only one of the four studies...demonstrated any difference from placebo in the 'nasal congestion/stuffiness' symptoms score." Although WellPoint concedes unpublished studies have shown significant benefits of Clarinex over placebo, the petition notes "final determination of potential clinical advantages for desloratadine...compared to older second-generation antihistamines awaits the performance of head-to-head trials of the products." As further support for its request that Clarinex be switched OTC, Seidman points out desloratadine "has a safety profile identical to loratadine...and is featured in direct-to-consumer advertising as having side effects similar to a sugar pill." While WellPoint says the timing of its petition is coincidental, the issue could surface during the April 22 Nonprescription/Pulmonary-Allergy/Dermatologic-Ophthalmologic Drugs Advisory Committee meeting; Seidman said he does not plan to speak at the meeting. Responding to WellPoint's petition, Schering said it would be a mistake to switch Clarinex OTC due to the lack of head-to-head trial data on the new drug. |