Sepracor Xopenex

Executive Summary

Levalbuterol promotion receives second letter from FDA regarding implied superiority in safety and efficacy for the single isomer product. A May 21 letter from the agency cites journal ads, a sales aid and a "Dear Doctor" letter for the tagline "The Right B-Agonist" as suggesting clinical superiority to racemic albuterol. FDA notes that in clinical trials "Xopenex .63 mg was demonstrated to be clinically comparable to 2.5 mg racemic albuterol sulfate, with only slightly less incidence of certain systemic beta-adrenergic side effects (e.g., tremor, nervousness), and only slightly less change in heartrate and plasma glucose." FDA also objects to statements like "We Wiped Out The (S)-Isomer. Your Patients Don't Need It," and "Xopenex contains only the therapeutically effective right (R)-isomer." FDA previously objected to similar claims made in Sepracor's press release announcing Xopenex' approval ("The Pink Sheet" April 26, p. 15). FDA requests that the company cease distribution of all Xopenex promotional materials that make such claims