By Cyndi Root
Strategic Science and Technologies LLC (SST) announced that it has optioned its topical ibuprofen (SST-0225) to an over-the-counter (OTC) healthcare company. SST announced the deal in a press release, stating that the exclusive option is for U.S. commercial rights to SST-0225 when approved by the Food and Drug Administration (FDA). The company didn’t disclose any of the deal’s financial terms.
Eric T. Fossel, Ph.D., Scientific Founder and CEO of SST, said, “This transaction provides SST with a very strong commercial partner to bring this important product directly to individuals who suffer from acute pain. The partner’s leadership in marketing and manufacturing high-quality healthcare products provides us with the widest distribution at an accessible price.”
SST-0225 is a patented formulation of ibuprofen. Engineered with SST’s KNOSIS delivery technology, the agent is a topical cream for the treatment of acute pain. The agent is in late-stage clinical development and offers advantages over currently available oral non-steroidal anti-inflammatory drug (NSAID) products. Those advantages include targeted local delivery, reduced systemic exposure, reduced adverse events, and a rapid onset of action.
Clinical trials of the agent in patients with pain from osteoarthritis or ankle sprain showed that SST-0225 was safe and well-tolerated, offering pain relief in the first 24 hours. The company states that the results may allow SST-0225 to be the first ever topical NSAID product. SST is utilizing the 505(b)(2) approval pathway to gain approval of the agent as a topical OTC product.
KNOSIS is SST’s novel topical technology based on Dr. Fossel’s work at Harvard Medical School. The company states that topical delivery approaches have not been successful due to the stratum corneum, the skin’s protective barrier. KNOSIS overcomes this barrier by increasing the active pharmaceutical ingredient’s (APIs) free energy, driving it into the tissue. Additionally, the formulation prevents hydrogen bond formation between the API and the stratum corneum, thereby improving the API’s ability to permeate the tissue. The method allows for increased local effect without the drug circulating much in the bloodstream and causing side effects.