Sunday, May 18, 2025
5/18/2025
GEL-FORMING SYSTEMS FOR ADHESION PREVENTION - DESCRIPTION (provided by applicant): Phase I study directed toward minimizing or preventing post-operative adhesion (POA) demonstrated that (1) a drug-free, gel-forming copolyester vehicle is more effective than hyaluronic acid (HA); (2) HA-based formulations are generally less effective than their non-aqueous copolyester, gel-forming counterparts; (3) antiangiogenic peptide and, in particular, the somatostatin analog (lanreotide acetate, LN) in a copolyester gel-forming vehicle are much more effective toward POA prevention than any other individual bioactive agent examined; and (4) certain anti-inflammatory drugs, and particularly, naproxen sodium (NP) have promising anti-adhesion properties. Phase 2 objectives are to (1) select an optimum gel-forming copolyester vehicle for the controlled release of an optimized, effective dose of NP and/or LN; (2) complete the development and scale-up studies of a selected formulation; and (3) initiate the safety study in collaboration with a marketing partner and complete commercialization plans for an anti-adhesion product in Phase II1. Accordingly, Phase II plans entail (1) optimizing the composition and volume of the non-aqueous, two-component, gel-forming copolyester gel-former (GF) to maximize its own ability to minimize POA, using a rat sidewall model (RT-SWM) and selecting one for testing the vehicle for the controlled release of naproxen sodium (NP) and/or LN; (2) optimizing the concentration of NP and LN in the selected GF composition to achieve maximum efficacy toward POA prevention using a RT-SWM; (3) determining the efficacy of selected combinations of NP and LN in GF using a RT-SWM; (4) conducting comparative studies of optimized NP, LN, and NP + LN formulations using a RT-SWM and a rabbit sidewall model (RB-SWM) and selecting one system for completing a study using a pig sidewall model (PG-SWM) for initiating additional studies as needed for regulatory approval; and (5) completing development and scale-up studies of the selected GF and its selected formulation.
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