Charting the Course of Lenabasum: A Case Study in CB2 Drug Development & Regulatory Strategy
- DEA scheduling challenges: Managing regulatory hurdles and delays tied to schedule I/ II status, including DEA registration and supply chain restrictions
- HAL study requirements: Conducting human abuse liability studies despite low CB2- related CNS activity, as mandated by the FDA
- Cost burden on development of schedule I/II Trials: High financial and operational costs due to added security, regulatory compliance, and limited manufacturing sites to choose from