Adalvo is very proud to announce that our Phase III Study for Pregabalin ER tablets has been completed successfully. The study was conducted with a patient population of over 450 patients, and more than 20 clinical sites. The study met all primary and secondary end points, well within the acceptance criteria, demonstrating convincing and robust data on the comparable safety and efficacy effect of our product in neuropathic pain patients.
Pregabalin is a backbone medication indicated in the treatment of Neuropathic pain. Having a unique formulation, the benefit of this product is increased patient adherence to the therapy through the reduction of the daily administration requirements.
Pregabalin annual sales is $2.3bn, according to 2021 IQVIA.
Based on this positive outcome, we will proceed with DCP filing in August 2022. Our goal is to offer the first once-daily Pregabalin formulation, available for patients in Europe, if approved by health authorities.
We are very proud to have achieved this extraordinary milestone, and being able to offer Pregabalin Extended-Release to patients in Europe and across the world.
Disclaimer: Pregabalin which is subject to patent protection is currently not offered or made available in countries where patents are in force