The Company targets launching sales of micro-emulsion alprostadil
injection in March 2011.
relaxes muscles in erectile tissue of the penis, allowing blood to flow in.
Men who can't tolerate any PDE-5 inhibitor or who are among the 20%-30% who don't respond can try Alprostadil
in injection or pellet form.
A system for inserting a pellet of alprostadil
into the urethra is marketed as Muse.
Even more encouraging, especially for men who cannot stand the thought of using a needle, is the recent availability of alprostadil
in the form of a tiny "seed" one places in the urethral opening at the tip of the penis, where it is quickly absorbed.
Apricus Bio incorporated alprostadil
with its NexACT delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis.
In a double-blind, placebo-controlled study patients were randomized to either placebo or topical alprostadil
in 100- or 400-[micro]g doses.
With both issued and pending patents, the company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil
, in the treatment of women with FSD.
However, it may become possible one day to administer the prostaglandin through a noninjectable means called transurethral alprostadil
, which works by delivering alprostadil
through the urethra in a small single-dose plastic applicator.
Food & Drug Administration (FDA) has granted the Company an Investigational New Drug application number for its NexACT-based alprostadil
treatment for Raynaud's syndrome, ahead of a pre-IND meeting in mid-July 2010 to discuss its proposed Phase 2/3 protocol.
Presentation Title: A randomized, placebo-controlled, double-blind, parallel design study of the efficacy and safety of specially formulated alprostadil
topical cream in patients with female sexual arousal disorder.
ALIBRA, a local therapy, consists of two drugs, alprostadil
and prazosin HCl, formulated into a microsuppository and delivered to the urethra (urine tube) via a single-use plastic applicator.