Therapeutic Area(s): Anxiety, Social Phobia, Sexual Dysfunction
Phase of Development: Phase II
TGWOOAA is unique in that it will be the first 5HT1A Agonist
& 5HT2 Antagonist on the market for the treatment of anxiety. TGWOOAA's mechanism of
action indicates that this product would be beneficial for both
anxiety and sexual dysfunction. Initially, this product will be developed
for social phobia. After the product is on the market, FKP plans
to register it for other indications such as generalized anxiety
disorder, mixed anxiety depression and sexual dysfunction.
TGWOOAA HCl is a nonbenzodiazepine anxiolytic
that should not have benzodiazepine-like or anticholinergic side
effects. Preclinical studies have shown it to have a very high
affinity for the serotonin 1A (5HT1A) receptor. In addition, TGWOOAA
has a high affinity for the serotonin 2 (5HT2) receptor. The 5HT1A
partial agonist and 5HT2 antagonist activities of TGWOOAA suggest
the agent will have beneficial properties for the treatment of anxiety and sexual dysfunction.
In Phase I trials TGWOOAA is safe and tolerated up to single
doses of 180 mg and multiple doses of 60 mg T.I.D. for 7 days.
Adverse effects were minimal consisting mostly of light headedness
and nausea. Several Phase II studies were conducted in both generalized
anxiety disorder. Signals indicating efficacy
were found. Phase III protocol for the existing
formulation has been submitted to FDA. An extended release
formulation will achieve better patient compliance and a lower
side effect profile. Presently, several different extended
release prototypes are in development. A new formulation will help to maximize the market potential
of this drug.
Developmental and marketing partnerships are available.