FDA hands back Adamis’ application for an ED drug, looking for more data

The micro cap San Diego-based biotech Adamis has stumbled badly in its attempt to get a lower-cost erectile dysfunction drug on the market.

The specialty pharmaceutical company — which focuses on developing cheaper drugs for various disorders — said the FDA had deemed its marketing application incomplete, handing back the application with a refusal-to-file notice and indicating the biotech did not include sufficient data to permit review. The experimental drug is a fast-disintegrating sublingual version of tadalafil.

Tadalafil is designed to treat erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia and forms part of a class of drugs called phosphodiesterase-5 (PDE5) inhibitors. Within this family of treatments, three oral ED tablets have already been approved: Tadalafil is the active ingredient in Lilly’s Cialis, sildenafil in Pfizer’s Viagra and vardenafil in GSK’s Levitra.

The agency has asked the company to provide longer real-time (versus accelerated) stability data as well as more dissolution data for both the clinical and registration batches, Adamis said, adding that it may request a meeting with the agency to map a path forward.

“We are obviously very disappointed with this development and are evaluating the letter,” Adamis chief Dennis Carlo said in a statement on Wednesday. The company’s shares $ADMP dipped about 13% in premarket trading.

Adamis — which already sells a low cost epinephrine injection called Symjepi via partner Novartis’ Sandoz unit to compete with Mylan’s Epipen — is also developing affordable drugs for asthma and opioid overdose.

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