Teva lifted by positive migraine drug results

pharmafile | May 15, 2015 | News story | Sales and Marketing |  TEV-48125, Teva, headaches, migraine 

Patients who take either dose of Teva’s investigational treatment for chronic migraine improve more than those taking a placebo according to new trial results.

TEV-48125 demonstrated statistically significant reductions in the primary endpoint – the number of hours patients had a headache, after one week of treatment. Around 15% of patients in the study were totally free of headaches after three months of treatment.

The monthly injectable monoclonal antibody reduced the number of hours people had headache after one week, and the number of days people had moderate or severe headaches after three months.

Teva will be hoping the results make TEV-48125 more attractive, as it will face a stiff challenge to bring an expensive biological injection to a market dominated by far cheaper oral treatments. But Michael Hayden, Teva’s president of global R&D and chief scientific officer, says the results are strong enough to give it an advantage over other available treatments.

“These results with TEV-48125 have not previously been achieved at any phase in chronic migraine. They are highly statistically significant, and provide a solid foundation to advancing the programme into Phase III. Patients who have suffered from chronic migraine for many years now have a very good reason for hope.”

The results of the Phase IIb study in 264 people with highly severe chronic migraines will be presented at the International Headache Congress in Valencia today. Dr Alan Rapoport, president of the International Headache Society, and clinical professor of neurology at The David Geffen School of Medicine at UCLA, Los Angeles, was involved in the study.

He says: “Chronic migraine represents an incredibly debilitating neurological disorder which significantly diminishes quality of life and disables the sufferers. Although all individuals with chronic migraine qualify for preventive therapy, most do not receive it and a substantial proportion of those who receive it end up discontinuing therapy.

“These data provide a basis for real hope for chronic migraine patients. The speed and magnitude of reductions in migraine hours and days seen in this trial may significantly, and positively, impact the lives of these patients.”

Lilian Anekwe