FDA, Regulatory

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.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 45,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->