The U.S. Food and Drug Administration has approved ZAVZPRET™ (zavegepant), a fast-acting nasal spray developed by Pfizer for the acute treatment of migraine with or without aura in adults. ZAVZPRET is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, offering a new delivery method for patients who may not respond well to oral medications. Marshall Morris, Partner at DelRicht Research, emphasized the importance of this innovation in expanding treatment options for migraine sufferers.

DelRicht Research, led by Dr. Patrick Dennis at Touro Medical Center in New Orleans, LA, played a key role in the pivotal clinical trials that supported the approval.

A Clinical Milestone for Migraine Relief

The FDA approval was based on results from two large, randomized Phase 3 studies evaluating pain freedom and relief from the most bothersome migraine symptoms at two hours post-dose. In addition to outperforming placebo on these co-primary endpoints, ZAVZPRET also showed early onset of relief as soon as 15 minutes and durable benefits lasting up to 48 hours in some patients.

Dr. Dennis, a seasoned investigator with extensive experience in central nervous system trials, was instrumental in enrolling a diverse patient population reflective of those who often suffer from migraines but are underrepresented in clinical research.

Marshall Morris on Bringing New Hope to Patients in Need

What sets ZAVZPRET apart is its nasal spray formulation, which allows for rapid absorption and ease of use, especially for migraine sufferers who experience nausea or difficulty swallowing pills during attacks. For those who cannot tolerate or don’t respond to oral therapies, ZAVZPRET represents an innovative alternative with proven effectiveness and tolerability. “We are proud to have contributed to the development of this important treatment,” said Marshall Morris, Partner at DelRicht Research. “The approval of ZAVZPRET reflects our continued commitment to bringing innovative therapies to patients and advancing clinical research, especially in high-need areas like migraine.”

“We are proud to have contributed to the development of this important treatment. The approval of ZAVZPRET reflects our continued commitment to bringing innovative therapies to patients and advancing clinical research, especially in high-need areas like migraine.”

— Marshall Morris, Partner at DelRicht Research

Innovation Through Partnership

The success of ZAVZPRET highlights the power of collaboration between research sites and sponsors. As Pfizer continues to expand its migraine portfolio, treatments like ZAVZPRET offer renewed hope for the nearly 40 million Americans living with this often-debilitating condition. Dr. Patrick Dennis shared, “ZAVZPRET provides a much-needed treatment option for patients who need fast and reliable relief. It’s rewarding to be part of research that has the potential to impact so many lives.”

“ZAVZPRET provides a much-needed treatment option for patients who need fast and reliable relief. It’s rewarding to be part of research that has the potential to impact so many lives.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

In conclusion, the FDA’s approval of ZAVZPRET marks an important advancement in migraine care. With strong contributions from DelRicht Research and experienced principal investigators like Dr. Dennis, this new therapy exemplifies how targeted innovation can lead to better outcomes for patients in real need.

Read the full press release from Biohaven (Pfizer).