FAMU’s First FDA-Approved Human Trial to Study CBD for Neuropathy
IPH Professor Mandip Sachdeva Approved for Groundbreaking Investigation
Tallahassee, FL – Great News: Mandip Sachdeva, Ph.D., Professor and Section Leader, Pharmaceutics in the FAMU CoPPS, IPH and Editor in Chief, CRC Critical Reviews in Therapeutic Drug Carrier Systems has received a letter from the U.S. Food and Drug Administration (FDA) for his Investigational New Drug (IND) indicating that it is Safe to Proceed, with no clinical holds. This IND includes his protocol entitled, “Effect of CBD Isolate and Full-spectrum, CBD on Diabetic Peripheral Neuropathy.”
The FDA has requested a few things for which Dr. Sachdeva, and his research team are developing a response, and further work is also being done. Nevertheless, there is no clinical hold, and this is just the beginning with several steps to follow:
- Get Institutional Review Board (IRB) approval from FAMU,
- Get IRB approval from Tallahassee Memorial Healthcare,
- Conduct stability studies throughout the period of the trial, and
- Patient selections, followed by the trials.
Seth Y. Ablordeppey, Ph.D., Professor and Eminent Scholar Chair in Biomedical Sciences | Interim CoPPS, IPH Dean remarked: “We congratulate Dr. Mandip Sachdeva on the FDA approval of his clinical trial protocol titled, ‘Effect of CBD Isolate and Full-Spectrum CBD on Diabetic Peripheral Neuropathy.’ This represents a pivotal step in the CoPPS IPH's commitment to advancing evidence-based research in pain management and neuropathic disorders.
This accomplishment by Dr. Sachdeva and his team underscores the dedication and scientific rigor of our researchers in exploring innovative, cannabinoid-based therapeutic options for diabetic peripheral neuropathy. As a leading institution in pharmacy and public health, we take great pride in contributing to groundbreaking studies that have the potential to enhance patient care and improve quality of life for those affected by chronic pain conditions."
Edward K. Agyare, Ph.D., Division Director & Professor, Pharmaceutical Sciences stated: "Congratulations to Dr. Sachdeva on the approval of your Investigational New Drug (IND) application from the FDA to conduct clinical trials. Your dedication and hard work have made a significant impact on advancing research in this area. We are incredibly proud of your achievements!"
According to Dr. Sachdeva, “This is a pivotal and exciting moment for FAMU, as it represents our first human clinical trial in collaboration with Tallahassee Memorial Healthcare. This initiative not only advances our research efforts but also strengthens our partnership in pursuing innovative healthcare solutions using cannabinoids. I am deeply grateful for the invaluable support from the University which has been instrumental in bringing this project to this level. I look forward to the next steps in this journey and the potential impact this study will have on improving patient outcomes in peripheral neuropathy.”
FDA’s Rigoberto Roca, MD Director | Division of Anesthesiology, Addiction Medicine and Pain Medicine | Office of Neuroscience | Center for Drug Evaluation and Research wrote in the congratulatory letter, in part: “We have completed our safety review of your protocol and have concluded that you may proceed with your proposed clinical investigation.”