Vernalis Successfully Completes Frovatriptan Phase III Open Label Safety Study in Prevention of Menstrual Migraine
20 December 2005
Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced the successful completion of a long-term Phase III open-label safety study of frovatriptan administered for six days a month for 12 months in the prevention of migraine in patients with migraines related to their menstrual cycles. In total, 525 patients entered the study and 308 (59%) completed all 12 treatment cycles with over 4,000 peri-menstrual periods treated during the study. A minimum of 100 patients completing the study was required to fulfil the safety data objective. The results indicate that the long-term safety profile observed in this trial is in line with previous data from shorter-term studies. The full results of the study will be presented at a scientific conference in due course.
The treatment regimen for frovatriptan in this study was identical to the higher dose regimen in the initial efficacy study, namely 5 mg twice daily on day one, followed by 2.5 mg twice daily for the remaining five days. Patients were instructed to begin treatment two days before their anticipated day of migraine headache.
Simon Sturge, CEO of Vernalis, said, “We are delighted to see that the results of this long-term safety study for frovatriptan are in line with our expectations. We now look forward to completion of the ongoing Phase III confirmatory efficacy trial in the first half of 2006 which, if positive, will be closely followed by submission to the FDA.”
Frovatriptan, marketed as Frova® in the U.S. by Vernalis’ partner, Endo Pharmaceuticals Inc., is a selective 5-HT1B/1D receptor agonist approved as an acute oral treatment for migraine headache and its associated symptoms. It is one of a class of prescription drugs called triptans that are approved for acute migraine indication.
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Enquiries:
Vernalis plc +44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
Julia Wilson, Head of Corporate Communications
Brunswick Group +44 (0) 20 7404 5959
Jon Coles
Wendel Verbeek
Notes to Editors
About Frova®
Frova® was approved by the FDA on November 8, 2001 for the acute treatment of migraine attacks with or without aura (subjective symptoms at the onset of a migraine headache) in adults. Frova® is generally well tolerated, with a side-effect profile that is typical of the triptan class of drugs. Frova® is indicated for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established. Frova® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of Frova® have not been established for cluster headache, which is present in an older, predominantly male population.
Frova® should not be given to patients with cerebrovascular syndromes, peripheral vascular disease, uncontrolled hypertension, ischemic heart disease, or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina or other significant underlying cardiovascular disease. Frova® should not be given to patients within whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.
The most common adverse events (≥4%) include dizziness, fatigue, paresthesia, flushing, and headache.
The FDA-approved dosing for Frova® is one 2.5 mg tablet up to three times within a 24-hour period. Frova® has not been approved by the FDA for any indications other than for the treatment of acute migraine headaches, and its safety and efficacy in other indications have not been established.
Frova® is licensed for this indication in the US. For other countries, check local prescribing information. Not necessarily licensed for this indication outside the US. Not for release in the UK.
About MRM
Menstrually Related Migraines (also known as MRM) can have a serious and debilitating impact on women’s lives because they last longer than non-menstrual migraines, tend to be associated with severe pain and come back more often. Patients with MRM may suffer from migraines at any time, although their migraine is frequently linked to their menstrual cycle. Over 60 percent of migraines in women are associated with menstruation. Pain from these monthly migraines can disrupt a woman’s ability to function for up to three days at a time.
About Vernalis
Vernalis is a specialty pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, frovatriptan and Apokyn®, and a development pipeline focused on neurology and central nervous system disorders. The company has five products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis is establishing a US commercial operation to promote Apokyn® and co-promote frovatriptan alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven, specialty pharmaceutical company. For further information about Vernalis, please visit www.vernalis.com.
Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
