Non-Steroidal Anti-Inflammatory
Drug Products:
PLx
has focused its development efforts on non-steroidal
anti-inflammatory drug products that have active ingredients
previously approved for marketing by the U.S. Food and
Drug Administration. This strategy reduces development
risks, as these active ingredients have well known safety
and efficacy profiles, and speeds product development,
as an expedited regulatory path called the 505(b)(2)
pathway is available for new drug products containing
these already approved active ingredients.
Similarly, the company has focused the development
of its lead products on indications where there is a
significant clinical need and large commercial opportunity,
such as in osteoarthritis, pain, fever and cardioprevention,
while advancing other candidates toward preclinical
proof-of-concept in more niche markets, such as in ulcerative
colitis and patent ductus arteriosus. In both cases,
PLx intends to enter into one or more strategic alliances
with partners who can enhance the value of these products
and speed their development and commercialization. |