Physician Views: Could Allergan's oral anti-CGRP therapy be practice-changing for acute migraines?

On Tuesday, Allergan announced positive data from the first of two Phase III studies for its oral CGRP inhibitor ubrogepant as a treatment for moderate-to-severe acute migraines - more here. We are snap-polling neurologists and primary care practitioners (based in the US and EU5) to gauge initial reaction to the data.

Data from the first of two Phase III studies shows that 19.2 percent and 21.2 percent of patients treated with orally administered ubrogepant 50mg and 100mg, respectively, were pain-free two hours after a single moderate-to-severe migraine attack versus 11.8 percent of patients treated with placebo.

In addition, 38.6 percent (50mg) and 37.7 percent (100mg) of patients treated with ubrogepant achieved absence of their most bothersome migraine-associated symptom two hours after dosing, versus 27.8 percent of patients treated with placebo.

At first glance, how compelling are these efficacy data?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

Ubrogepant was well tolerated with an adverse-event profile similar to placebo. The most common adverse events were nausea, somnolence, and dry mouth, none of which were reported with a frequency of ≥5%. In terms of hepatic safety, across all treatment arms including placebo, there were six cases with aminotransferase (ALT or AST) elevations greater than three times the upper limit of normal (ULN); there were alternative explanations in all cases (concomitant illness or medication) and none were noted by the liver safety adjudication board to have a probable relationship to ubrogepant. There were no cases of Hy's Law.

At first glance, how compelling are these safety data?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

If data from a second, ongoing Phase III study are comparable or superior to those already presented, would you consider ubrogepant to be potentially practice changing for the acute treatment of moderate-to-severe migraines?

Yes

Yes - but only in patients unresponsive to triptans if data is positive in this subset

No

Approximately what proportion of patients currently treated for moderate-to-severe acute migraines would you expect to be treated with ubrogepant five years post-launch?

-

Based on the data above, how quickly (if approved) do you think ubrogepant would be integrated into the treatment paradigm?

Very slowly

Slowly

Moderately

Quickly

Very quickly

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by Medefield MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

To read more Physician Views articles, click here.