Ampyra 10mg Beats 5mg, But Weak Overall Results Net Neutral For ACOR
(Thomson Reuters ONE) -
Acorda Therapeutics (NASDAQ:ACOR) reported this morning that a 5mg dose of
Ampyra was not as effective as the approved dose, Ampyra 10mg. The FDA required
the company to conduct the low dose study when it originally approved the drug,
which is used to help multiple sclerosis (MS) patients walk better.
Neither dose met the primary endpoint in the FDA-mandated trial reported today.
However, the company emphasized that when endpoints similar to those used for
the approval of Ampyra were analyzed, the 10mg dose showed statistically
significant improvements vs. placebo in average walking speed and the number of
responders to treatment, while the 5mg did not.
Despite the "positive news" that a half a dose will not replace a full dose, the
negative study results from the trial reported today could give doctors pause
when prescribing Ampyra and sales of the drug could flatten or decline.
Additionally, health insurers could push back even harder then they already are
when considering paying the heavy price tag for Ampyra's limited benefit. What
the FDA will do with the data, such as including the new trial results in
Ampyra's label, is also a risk. Surprisingly, patients on either dose of Ampyra
did not perceive a significant improvement vs. placebo in the trial, but the
company noted that this was just a 4-week trial, shorter than the trials used to
support approval. While ACOR could start the day higher today, shares may fade
as investors digest the negative aspect of the results and after Shorts have
covered.
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Datum: 13.08.2012 - 16:30 Uhr
Sprache: Deutsch
News-ID 174051
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