Topamax Launch For Migraine Prevention Includes Unbranded DTC Ad
This article was originally published in The Pink Sheet Daily
Executive Summary
Rollout of Ortho-McNeil's disease awareness ad coincides with sales force launch meeting for the new indication. The ad directs patients to a toll-free phone number and a website.
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Controlled-release topiramate was designed to avoid dosing and tolerability issues seen in obesity trials with immediate-release formulation. Phase II study in diabetes-related obesity shows no advantage for long-acting version, J&J says; the formulation remains under evaluation for other indications.
J&J Weighs Topamax Controlled-Release Formulation After Dropping Obesity Program
Controlled-release topiramate was designed to avoid dosing and tolerability issues seen in obesity trials with immediate-release formulation. Phase II study in diabetes-related obesity shows no advantage for long-acting version, J&J says; the formulation remains under evaluation for other indications.
Topamax Promotions Draw FDA Warning Letter For Omitted Safety Information
Agency cites J&J website and sales aid for making tolerability claims without including sufficient risk information.