Shots:

• The two pivotal study conducted for assessing ubrogepant (50/100) vs usual care & ubrogepant (100) vs PBO for 1year & 8 wks. respectively to treat migrane in adults- evaluating its safety- tolerability & hepatic safety
• UBR-MD-04 (N=1-254) & 3110-105-002(N=516) study results: 21-454 migraine attacks were treated with 31-968 doses of ubrogepant with mean number 25.5 (50 mg) and 27.2 (100 mg) @52wks.; no signal of drug-induced liver injury or a hepatic safety concern was observed
• Allegan plans to file NDA submission with efficacy and safety results from ACHIEVE I & II (UBR-MD-01 & UBR-MD-02)- UBR-MD-04 & 3110-105-002 in H1’19

Ref: Novartis | Image: Endpts