Veterinary Development of Substance P-Saporin (SP-SAP)

A quick update on the pursuit of conditional approval of SP-SAP to  treat bone cancer pain in dogs. The FDA has already approved Minor Use/Minor Species (MUMS) designation for the drug, providing extended market exclusivity to treat the >10,000 annual cases of canine bone cancer-related pain, and the ability to commercialize the drug as soon as conditional approval is given.  An unexpected delay has occurred with the CMC (Chemistry, Manufacturing, and Controls) portion of the Conditional Approval application.  The drug used in the veterinary studies was prepared in a facility approved for Phase I/II clinical trial use, but not for commercial release of an FDA-approved drug.  SP-SAP will need to be produced in a facility approved for commercial release of an FDA-approved veterinary drug.  This is proving to be a difficult task.  Many facilities are approved at this level, but will not produce a veterinary drug until it is approved as a human drug.  We will keep looking.

Given the FDA’s receptiveness to the drug, clinical studies are in the planning stages to evaluate its effectiveness in the almost 10 million cases of osteoarthritis in dogs, as well as chronic pain in cats.  With the proper funding/partner, these studies could begin now with the SP-SAP already produced.

The drug, Substance P-Saporin (SP-SAP), has demonstrated remarkable pivotal-study efficacy as viewed in this video of one of the canine patient participants in the pilot veterinary clinical trial (Otis Patient Video, <2 min). Based on the impact of SP-SAP on the observable level of pain in these companion animals, the Center for Veterinary Medicine (CVM) is encouraging a multi-center efficacy trial to gain rapid full-approval for SP-SAP. Contract Research Organizations (CRO’s) have been put in place to provide GMP manufacturing, packaging, and labeling of the drug. Four veterinary specialty hospitals across the U.S. have been identified and coordinated for the multi-center efficacy trial. The expected success in this trial will provide full approval for SP-SAP, putting relief from all chronic pain indications within reach for companion dogs. Pain would no longer be a life-threatening disease for family pets