Allergan Reports Acceptance of NDA from FDA for its Ubrogepant for Migraine

Shots:

• The NDA filing is based on P-III ACHIEVE I (50 mg/100 mg) & ACHIEVE II (25mg/50mg) + two additional safety studies (UBR-MD-04 & 3110-105-002) assessing Ubrogepant vs PBO in patients with acute migraine
• The ACHIEVE I & ACHIEVE II studies resulted in meeting its 1EPs and 2EPs i.e, reduces the pain with no bothersome symptoms and was well tolerated
• Ubrogepant is a novel, oral gene-related peptide (CGRP) receptor antagonist and is used for broad spectrum treatment of migraine from episodic to chronic

Click here to read full press release/ article | Ref: Allergan | Image: Axios