Clinical
Data, Inc. (NASDAQ: CLDA) announced today that the United States
Adopted Name Council (USAN) has approved the generic name vilazodone
hydrochloride. Vilazodone,
if approved, would represent a first-in-class drug for the treatment of
depression, due to its novel dual mechanism of action as both a potent
and selective serotonin reuptake inhibitor (SSRI) and a partial agonist
of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus,
vilazodone combines first-line therapy for depression with 5-HT1A
partial agonism, an accepted adjunctive treatment for depression and a
first-line therapy for anxiety disorders. Clinical Data has recently
completed the second of two positive Phase III registration studies.
Results of these studies will form the basis of a new drug application
(NDA) that the Company intends to submit with the U.S. Food and Drug
Administration (FDA) by the end of 2009.
The purpose of the USAN Council is to select simple, informative and
unique nonproprietary names for drugs based on pharmacological and/or
chemical relationship. The American Medical Association, the United
States Pharmacopeial Convention and the American Pharmacists Association
sponsor the Council. The Council works closely with the World Health
Organization’s International nonproprietary Name Program.
On June 2, 2009, Clinical Data announced top-line results from its
second Phase III studies for vilazodone, with results confirming its
prior positive Phase III trial. Vilazodone was generally well-tolerated
and met both the primary and secondary endpoints of the study with high
statistical significance. In addition, study findings corroborate that
effects of vilazodone on sexual function were comparable to placebo when
measured by an objective validated scale, an important finding since
many antidepressants have been associated with causing or exacerbating
sexual dysfunction. In this second study, the most frequent side effects
associated with vilazodone were diarrhea, nausea, and headache.
The Company has projected that its current cash will be sufficient to
fund operations through the submission of the NDA for vilazodone this
year, as well as the commencement of its Phase III clinical program for
Stedivaze, a vasodilator used for cardiac stress testing, anticipated in
the next month.
