Agile Therapeutics has concluded patient recruitment in its pivotal, contraceptive patch, AG200-15 Phase 3 New Choice Study, comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.
The company has recruited around 1500 women two months ahead of schedule at over 100 sites throughout the US.
Following the completion of the the patient recruitment, Agile plans for an earlier submission of the new drug application (NDA) for AG200-15 to the US Food and Drug Administration (FDA).
Agile president and CEO Thomas Rossi said that they are very pleased to complete enrollment in the New Choice Study ahead of schedule.
“The rapid enrollment rate, 1500 women in eight weeks, reflects a broad interest amongst contraceptive users for the convenience of a once weekly contraceptive patch,” Rossi said.
“We look forward to the continued progress of AG200-15 and anticipate the expedited timeline will enable us to file for FDA approval earlier than previously anticipated.”
Agile Clinical Research and Development chief medical officer and vice president Marie Foegh said that physicians perceive a large need among their patients for the comfort and convenience of Agile’s low-dose, weekly contraceptive patch, and we are very pleased to potentially make our patch available earlier than anticipated.