Overly Aggressive Prialt Dose Data Are Not Surrogate Endpoints, FDA Says
This article was originally published in The Pink Sheet Daily
Elan had proposed accelerated approval of the intractable pain therapy in lieu of an agency-requested third pivotal trial, agency review documents show.
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Intrathecal therapy is indicated for "the management of severe chronic pain in patients…who are intolerant or refractory to other treatment." Elan will promote the non-opioid therapy with 40 to 50 sales reps targeting 3,000 doctors.
Amendment sets user fee date in December. Submitted Phase III study, which FDA requested in its second “approvable” letter for Prialt, shows significant results for lower doses of the non-opioid analgesic.
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