) recently announced that their drug, Horizant, has been approved
by the US Food and Drug Administration (FDA) for the management of
postherpetic neuralgia (PHN) in adults.
PHN is a nerve pain that follows herpes zoster (shingles).
According to Glaxo and XenoPort, approximately 100,000 patients
develop PHN in the US annually.
Glaxo had submitted a supplemental New Drug Application (sNDA)
to the FDA in August 2011. The approval was based on data from a
12-week principal efficacy trial and two supportive studies. A
total of 574 PHN patients above 18 years were enrolled in these
three studies. All three studies met their primary endpoints.
Horizant is already approved in the US for the treatment of
moderate-to-severe primary restless legs syndrome (RLS) in adults.
However, the product is not recommended for use in patients who are
required to sleep during the day and remain awake at night.
Glaxo and XenoPort have co-development and co-promotion rights
in the US for Horizant. Astellas Pharma Inc. has exclusive rights
to the drug in Japan and five other countries in Asia. Astellas
markets the drug in Japan under the trade name Regnite for the
treatment of RLS. Xenoport has rights to Horizant in the rest of
the world. The first commercial sale of the product, following the
PHN approval, will result in a $10 million milestone payment from
Glaxo to XenoPort.
We currently have a Neutral recommendation on both Glaxo and
XenoPort. Both stocks carry a Zacks #3 Rank ('Hold' rating) in the
GLAXOSMITHKLINE (GSK): Free Stock Analysis
XENOPORT INC (XNPT): Free Stock Analysis Report
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