Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor

   Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose
  Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with

PR Newswire

MIAMI, FL and NEW YORK, NY, March 4, 2013

MIAMI, FLand NEW YORK, NY, March 4, 2013 /PRNewswire/ --Noven
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug
Administration (FDA) Reproductive Health Drugs Advisory Committee voted 10 to
4 that the overall risk/benefit profile of low-dose mesylate salt of
paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval. LDMP is
an investigational nonhormonal treatment specifically developed for moderate
to severe vasomotor symptoms (VMS) associated with menopause.

Additionally, the committee voted:

  o7 to 7 that, based on pre-specified analyses, there is sufficient evidence
    to conclude that LDMP is effective in treating moderate to severe VMS
    associated with menopause; and
  o10 to 4 that, based on pre-specified analyses, there is not sufficient
    evidence to conclude that the change from baseline in VMS frequency is
    clinically meaningful to women.

The FDA is not bound by the recommendations of its advisory committees, but
will consider their guidance during the ongoing review of the New Drug
Application (NDA) that was submitted for LDMP in August 2012. The scheduled
Prescription Drug User Fee Act (PDUFA) action date for LDMP is June 28, 2013.

"As conveyed during Noven's presentation, we believe our clinical trial data
support LDMP as a safe, effective nonhormonal treatment option offering
clinical benefit to menopausal women," said Joel S. Lippman, M.D., Noven's
Executive Vice President – Product Development and Chief Medical Officer.
"While we are disappointed in today's outcome, we appreciate the discussion
and will work closely with the FDA as it completes its ongoing evaluation."

Moderate to severe VMS affect approximately 24 million menopausal women in the
United States and approximately two-thirds are not currently treating their
VMS with either prescription medication or over-the-counter supplements. There
are currently no FDA-approved nonhormonal options for the treatment of VMS.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in
the research, development, manufacturing, marketing and sale of prescription
pharmaceutical products. Noven is committed to developing and offering
products and technologies that meaningfully benefit patients, its customers
and its industry partners, with a focus on treatment options for women
experiencing menopausal vasomotor symptoms. Noven is a stand-alone operating
subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as
Hisamitsu's U.S. growth platform in prescription pharmaceuticals. For more
information about Noven, visit information about Hisamitsu,

Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.

Samantha Schwarz
Executive Director

SOURCE Noven Pharmaceuticals, Inc.

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