FROM: WE MOVE
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From: "WE MOVE" <[log in to unmask]>
To: [log in to unmask]
Date: Thu, 22 Apr 2004 14:22:44 -0400
Subject: FDA Approves Apomorphine Injectable; Trial of Fast-Dissolving
Selegiline in PD
Message-ID: <[log in to unmask]>
Thursday, April 22, 2004 Issue 8 VOLUME 1 ISSUE 8
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CONTENTS
FDA Approves Apomorphine Injectable
Trial of Fast-Dissolving Selegiline in PD
FDA Approves Apomorphine Injectable
The United States Food and Drug Administration has given approval to
Apokyn, the brand name for apomorphine hydrochloride injectable from
Bertek Pharmaceuticals. Apokyn is approved for the treatment of acute,
intermittent treatment of hypomobility, "off" episodes ("end-of-dose
wearing off" and unpredictable "on/off" episodes) associated with
advanced Parkinson's disease. According to the company press release, the
product will be available by July 2004 and distributed through a limited
specialty pharmacy network.
Further information is available from Bertek
( http://www.bertek.com/company/newsroom.cgi?ID=1082645223 )
and from the FDA
( http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01284.html
Trial of Fast-Dissolving Selegiline in PD
Zydis selegiline reduces off time in Parkinson's disease patients with
motor fluctuations: A 3-month, randomized, placebo-controlled study
CH Waters, KD Sethi, RA Hauser, E Mohlo, JM Bertoni, Zydis Selegiline
Study Group
Movement Disorders 2004;19:426-432
A rapidly dissolving formulation of selegiline is effective as an adjunct
treatment for PD, according to this study. "Zydis" is a brand name for a
tablet formulation that dissolves rapidly in the mouth, promoting oral
uptake and minimizing first-pass metabolism.
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