A Phase III clinical study sponsored by Adalvo has been published in the Journal of Pain Practice, demonstrating that the once-daily prolonged-release (PR) formulation of Pregabalin is as effective and safe as the established immediate-release (IR) version (Lyrica®) in treating patients with diabetic peripheral neuropathy (DPN).
The randomised, double-blind, placebo-controlled study evaluated 453 patients over a 13-week period. Results showed that the PR formulation achieved similar reductions in weekly pain scores compared to the IR product, with both significantly outperforming the placebo. The study highlights the therapeutic value of the PR format, offering patients a simplified dosing option without compromising efficacy or safety.
Pain from diabetic peripheral neuropathy affects millions worldwide, often with a heavy toll on quality of life. While medication can offer relief, the burden of frequent dosing remains a challenge for many patients.
Adalvo has also successfully launched Pregabalin PR across key European markets, making it the first and only company to do so. This achievement reflects the company’s ability to translate scientific investment into patient-accessible therapies.
The European market for Pregabalin products reached $765 million in 2024 (IQVIA), reflecting the continued demand for effective and patient-friendly treatments for neuropathic pain.
At Adalvo, our purpose extends beyond formulations. We sponsor studies like this because we believe that science must serve the patient, not the other way around. When one pill a day can offer the same relief as two, the decision to invest in that possibility becomes clear.
This study is now accessible in full via the Journal of Pain Practice: https://doi.org/10.1111/papr.70061
For partnership opportunities or further information about our pregabalin PR offering, please contact the team today.