) announced that the US Food and Drug Administration (FDA) has
approved Zecuity (sumatriptan iontophoretic transdermal system)
for the acute treatment of migraine with or without aura in
adults. Zecuity, a single-use, battery-powered patch, actively
delivers sumatriptan through the skin. Zecuity provides relief to
both migraine headache pain and migraine-related nausea
The regulatory approval was based on data from an extensive
development program comprising phase III trials. The program
included 800 patients using more than 10,000 Zecuity patches.
Zecuity treated twice the number of patients than placebo.
Moreover, 53% of the patients in the Zecuity arm achieved relief
from headache as compared to 29% in the placebo arm. 84% of
patients in the Zecuity arm were nausea free at two hours as
compared to 63% of the patients treated with placebo. This study
proved Zecuity to be safe and effective in treating migraine and
relieving its cardinal symptoms two hours after patch
NuPathe is currently looking for a commercial partner and
expects to launch the drug in the fourth quarter of 2013.
Imitrex is also approved for the treatment of migraine with or
without aura in adults.
We are positive on the FDA approval as Zecuity is the first
and only FDA-approved migraine patch. Zecuity's regulatory path
in the US has not exactly been smooth with the company receiving
a complete response letter from the FDA in Aug 2011. Therefore,
Zecuity's approval is a major milestone for NuPathe.
We currently have a Neutral recommendation on NuPathe, Inc.
With Zecuity gaining FDA approval, we expect the company to
announce a partnership deal shortly. The stock carries a Zacks
Rank #3 (Hold). Right now,
Valeant Pharmaceuticals International, Inc.
) displays better fundamentals and looks more attractive with a
Zacks Rank #1 (Strong Buy).
GLAXOSMITHKLINE (GSK): Free Stock Analysis
NUPATHE INC (PATH): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.