Positive phase III ACHIEVE II trial results for ubrogepant published in The Journal of the American Medical Association.- Allergan

Allergan plc announced that positive results from ACHIEVE II (UBR-MD-02), a pivotal Phase III clinical trial evaluating the efficacy, safety and tolerability of ubrogepant, have been published in the November 19th issue of The Journal of the American Medical Association (JAMA) . These data reinforced that acute treatment of migraine with ubrogepant compared with placebo led to significantly greater rates of pain freedom at two hours with both the 50 mg and 25 mg doses, and freedom from the most bothersome migraine-associated symptom at two hours with the 50 mg dose. If approved, ubrogepant would potentially be the first FDA-approved small molecule, oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine.

The ACHIEVE II trial evaluated ubrogepant 50 mg and 25 mg, compared with placebo, across a wide range of clinical endpoints, including the co-primary endpoints of pain freedom (no pain) and freedom from the most bothersome migraine-associated symptom at two hours post-initial dose. For the two co-primary endpoints, ubrogepant 50 mg and 25 mg showed statistically significant higher response rates for pain freedom at two hours (21.8% for 50 mg, 20.7% for 25 mg and 14.3% for placebo), and the 50 mg dose demonstrated statistically significant higher response rates for the freedom from the most bothersome migraine-associated symptom at two hours (38.9% for 50 mg and 27.4% for placebo). Additionally, ubrogepant 50 mg was statistically superior to placebo in the absence of light sensitivity (43.8% for 50 mg and 35.5% for placebo) and sound sensitivity (54.1% for 50 mg and 46.3% for placebo).

Ubrogepant studies show that both the 50 mg and 25 mg doses were well tolerated with an adverse event profile similar to placebo. The most common adverse reaction during the single attack studies (occurring with an incidence greater than 2 percent and at least twice the rate of placebo) was nausea (incidence 2-4%). In a year-long extension study, the most common treatment-related adverse event was also nausea, with an incidence less than 2 percent.

See- " Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial"- Richard B. Lipton, MD; David W. Dodick, MD; Jessica Ailani, MD; ,et al. JAMA. 2019; 322(19):1887-1898. doi: 10.1001/jama.2019.16711.

A Prescription Drug User Fee Act (PDUFA) target date for the ubrogepant NDA has been set for the 4th quarter of 2019.