A.P. Pharma, Inc.
(OTCBB: APPA.OB), a specialty pharmaceutical company, today reported it has initiated a program to expand its pipeline of sustained release products, including a new program targeting the relief of post-surgical pain. The company also announced it will pursue a post-approval expansion of its leading drug program for the treatment of chemotherapy-induced nausea and vomiting (CINV) with the goal of demonstrating the utility of its lead agent, Sustol™(formerly known as APF530) in the treatment of delayed onset CINV in patients receiving highly emetogenic chemotherapy (HEC) agents. Currently there is no approved 5-HT3 receptor antagonist for the treatment of delayed HEC.
“AP Pharma continues to make significant progress toward resubmission of the NDA for Sustol targeted for the end of the first quarter 2014,” said Dr. Barry Quart, CEO of A.P. Pharma. “Our plan to initiate a new clinical trial to further expand the potential label is an indicator of our high level of confidence in this product and is part of a broader plan to build a CINV franchise. With the anticipated FDA approval of our lead product, it will be much more efficient to develop and register other drugs utilizing the same proprietary, Biochronomer™, sustained-release technology. We are very excited to move our most advanced program for post-surgical pain relief into full-scale development. This product candidate has the potential to significantly reduce the need for opiates post-surgery and reduce the length of hospital stay post-surgery.”
Post-surgical Pain Program
A.P. Pharma’s pain relief program utilizes the company’s polymer-based Biochronomer drug delivery platform to continuously release anesthetic agents directly at the source of pain over a period of several days. The company is targeting a prolonged period of anesthetic release such that therapeutic concentrations of active drug are achieved rapidly and maintained for at least 72 hours. The potential benefit of A.P. Pharma’s prolonged release profile is to achieve rapid pain relief, maintaining higher levels of active drug at the site of the pain over time to potentially provide greater relief from pain, and to maintain pain relief for up to 5 days following surgery. The current market leader, Exparel®, reduced mean pain intensity only during the first 24 hours following study drug administration; between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments.