The U.S. Food and Drug Administration recently declined to approve Adamis Pharmaceuticals’ alternative to the erectile dysfunction drug cialis.
After preliminary review, the FDA requested additional data on Adamis’ APC-8000, which the company has said could potentially be an improved version of cialis from drugmaker Sanofi. In December, San Diego-based Adamis submitted a new drug application to the FDA.
“We are obviously very disappointed with this development and are evaluating the letter and what the FDA has requested. We intend to work closely with the FDA to try to clearly map the path forward,” Dennis J. Carlo, president and CEO of Adamis, said in a statement.
The FDA asked that Adamis’ resubmitted application include “longer real-time (versus accelerated) stability data and additional dissolution data for both the clinical and registration batches.”
Adamis can ask the FDA for a Type A meeting, intended for stalled product development, to seek additional guidance.
The company’s lower-cost epipen alternative recently launched, via partner Sandoz.