NURTEC® is the first and only oral medicine approved for both acute and prophylactic migraine treatment.
SINGAPORE, 20 January 2024 – Pfizer today announced the availability of NURTEC® (rimegepant) in Singapore, an orally disintegrating tablet 75mg for both the acute treatment of migraine with or without aura in adults and the prophylaxis treatment of episodic migraine in adults who have at least four migraine attacks per month.1 There is an estimated up to 10% of the population living with migraine in Singapore2 and it is one of the leading causes of disability worldwide.3,4 Migraine disproportionately affects women over three times more often than men.5
“We are pleased to introduce NURTEC® to Singapore, a treatment addressing both the immediate relief and preventive needs of migraine sufferers. We recognise the profound impact migraine has on every aspect of patients’ lives, from professional obligations to personal well-being,” said Deborah Seifert, Cluster Lead, Malaysia-Indonesia-Singapore-Philippines (MISP), Pfizer Emerging Markets Asia. “In the face of one of the most persistent healthcare challenges, Pfizer remains committed to our mission: to create breakthroughs that change patients' lives. This ethos continues to stay at the top of our minds as we discover, develop and ensure availability and access to advanced medicines and vaccines.”
Results from the Phase 3 study published in Lancet demonstrated that a single dose of NURTEC® provided superior pain reduction and reductions in associated symptoms of migraine at two hours compared to placebo.6 The prevention study, also published in Lancet, demonstrated that NURTEC® taken every other day provided superior reduction in the number of days per month with migraine in Weeks 9 –12 of the 12-week treatment period compared to placebo, that was maintained with continued dosing during the 12-month open-label extension period.7
"Migraine is more than just headache; it is a complex neurological condition that is episodically severely disabling, often leading to a significant decrease in quality of life. Conventional treatments sometimes fall short, either due to lack of efficacy or side-effects that can leave many patients in a perpetual search for relief,” said Professor Peter Goadsby, Professor of Neurology, King’s College London, who is one of the physicians in a partnership that discovered a biological mechanism that led to the formation of this new class of medication. “Rimegepant represents a significant stride forward. By addressing both preventive needs and acute attack relief, including pain, with a single medication. This new class of medication, gepants, has the potential to redefine the standard of care and provide hope to those who have long felt underserved by existing migraine treatments.”
Rimegepant is approved in over 40 markets to date8, including in the United States, and in the European Union and the United Kingdom under the brand name VYDURA® ODT. Additional regulatory applications are under review around the world.
NURTEC® is now available in Singapore. Healthcare professionals will be able to decide how they want to prescribe NURTEC® based on the locally approved dosing.
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About Migraine
More than one billion people worldwide live with migraine,9 and the World Health Organization classifies migraine as the second leading cause of disability in the world.3,4 Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).10
About NURTEC® (rimegepant)
NURTEC® targets a key component of migraine by reversibly blocking CGRP receptors. CGRP is increased during a migraine attack, dilates blood vessels and is involved in nociceptor signaling.11 CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the endogenous CGRP neuropeptide.12
The Marketing Authorization for NURTEC® was based, in part, on the review of the results from three Phase 3 studies for acute treatment, a long-term, open-label safety study in acute treatment of migraine and a Phase 3 study with a 1-year open-label extension in the preventive treatment of migraine. NURTEC® is taken orally as needed, up to once daily, to stop migraine attacks or taken every other day to help prevent migraine attacks.
The most frequent adverse event in clinical trials with NURTEC® was nausea for acute treatment (1.2%) and for migraine prophylaxis (1.4%).12 Most of the reactions were mild or moderate in severity.12 Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated.12 No clinical trial data have yet suggested NURTEC® to have addiction potential, or that it is associated with medication overuse headache or rebound headache.12,13
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.sg. In addition, to learn more, please visit us on www.Pfizer.com.sg and like us on Facebook at Facebook.com/PfizerSG.
References:
1. NURTEC® Prescribing Information Patient Information Leaflet. Pfizer. Jan 3, 2024. Accessed: https://labeling.pfizer.com/ShowLabeling.aspx?id=18088
2. Statistics by National University Hospital Division of Neurology 2018. Today Online. Aug 11,2018. Accessed: https://www.todayonline.com/singapore/more-just-bad-headache
3. Brain Research UK. Migraine. Available at: https://www.brainresearchuk.org.uk/neurological-conditions/migraine. Last accessed: May 2023.
4. Steiner TJ, Stovner LJ. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21:137.
5. Al-Hassany L, Haas J, et al. Giving Researchers a Headache – Sex and Gender Differences in Migraine. Front Neurol. 2020;11:549038.
6. Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomized, phase 3, double-blind, placebo-controlled trial. Lancet 2019;394 :737–45.
7. Croop R, Lipton RB, Kudrow D, Stock DA et al. Oral Rimegepant for preventive treatment of migraine: a phase 2/3, randomized, double-blin, placebo-controlled trial. Lancet 2021: 397:51-60.
8. Pfizer. Data on file.
9. Ryvlin P, Skorobogatykh K, Negro A, et al. Current clinical practice in disabling and chronic migraine in the primary care setting: results from the European My-LIFE anamnesis survey. BMC neurology. 2021;21(1):1.
10. International Headache Society. The International Classification of Headache Disorders, 3rd edition. Cephalagia. 2018;38(1):1-211.
11. Durham P. Calcitonin Gene-Related Peptide (CGRP) and Migraine. Headache. 2006;46:S3–S8.
12. European Medicines Agency. Vydura - Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/vydura-epar-product-information_en.pdf Last accessed: May 2023.
13. Caronna E, Starling A. Update on Calcitonin Gene-Related Peptide Antagonism in the Treatment of Migraine. Neuro Clin. 2021; 39(1):1-19