Particle Sciences, a drug delivery contract development and manufacturing organization, has been contracted by BHR Pharma to develop an in-field nasally applied formulation of progesterone for traumatic brain injury (TBI).
BHR Pharma is pioneering this treatment and is well into their study, SyNAPSe (study of the neuroprotective activity of progesterone in severe traumatic brain injuries), a global, Phase 3, multi-center pivotal trial in severe TBI using a parenteral formulation that was independently developed.
Particle Sciences CEO Dr Mark Mitchnick noted the organization focuses on formulation design and manufacturing.
"Our clients often face challenging delivery issues so the dosage forms we work with frequently require a high level of engineering and the simplification of complex formulation challenges to commercially viable products. In this case, the challenge was achieving rapid onset under conditions of true duress, trauma.
"The product had to be versatile and durable. BHR are world leaders in this therapeutic approach and working with their technical team we have been able to design a dosage form that meets their needs. We look forward to helping BHR bring this very important product into the clinic and through to commercialization."