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

A groundbreaking pain therapeutic is poised for conditional approval in 2015 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. 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.

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