- Relpax® Migraine 40mg (eletriptan) is now available from pharmacies without a prescription (Pharmacist Only Medicine) in two-tablet packs.
- Until the triptan down-scheduling 4.9 million Australians suffering from migraine have had to rely on simple pain relief medication and managing prescriptions with general practitioners (GPs).
- The launch of Relpax® Migraine comes after a TGA decision to down schedule triptans to optimise the outcomes of patients living with migraine.
AUSTRALIA, 26 June 2023 – Viatris Inc., a global healthcare company has announced that Relpax® migraine (eletriptan) is available over the counter following the decision to down schedule the medicine from Schedule 4 (Prescription Only Medicine) to Schedule 3 (Pharmacist Only Medicine)1. The decision to approve Relpax® Migraine was made by the Therapeutic Goods Administration (TGA) which opens a pathway for patients suffering from migraine to access treatment earlier and to return to their everyday life sooner2.
Migraine is a neurological condition that affects 4.9 million Australians but is commonly misunderstood and many members of the public believe that they are experiencing a bad headache3. However, migraine has associated symptoms including sensitivity to light or noise, nausea, fatigue, irritability, stiff neck, and an aura in some—a sensory disturbance such as seeing zigzag lines across vision or tingling hands4. When it occurs, migraine headaches may persist for between four and 72 hours, debilitating the individual from enjoying everyday life4.
Migraine & Headache Australia representative Carl Cincinnato says “As someone who has lived and struggled with migraine for decades, I know firsthand the challenges people face when it comes to treating a migraine attack when symptoms begin. Being able to access treatment as soon as possible, means you have a better opportunity to get back to everyday life sooner and take more control over the condition.”
Before the down-scheduling, if a patient is experiencing migraine and does not have a prescription, they would only have the option to access simple pain relief medications such as non-steroidal anti-inflammatory drugs (NSAIDs)2. For many patients, this does not provide adequate relief and the symptoms can have emotional and psychological impact and prevent patients from contributing to their everyday life3.
Viatris Australia Country Manager, Sylvain Vigneault says “Viatris has a long-standing commitment to improving patient access to high quality, affordable medicines. Given the high impact on quality of life for patients, there is a clear need to increase awareness of the burden of migraine and for patients to have better access to effective treatment when they suffer from migraine. We are proud of the work that’s gone into the regulatory process to achieve this outcome for patients living with migraine.”
Following the successful change of the down scheduling of other triptans in Australia, Viatris made a submission to the Therapeutic Good Administration (TGA) to register a Schedule 3 eletriptan (active ingredient) product, namely Relpax® Migraine. Subsequent applications to the TGA focused on updating critical health information on the packaging to provide the patient with key specific information on the product once it has been dispensed by the pharmacist.
Cynthia Tan, Viatris Australia Head of Medical Affairs says, “From our unique vantage point, we have the ability to touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases. We put the person at the centre of their own unique health journey. The down scheduling of triptans will hopefully provide easier access to the medicines for patients who have difficulty accessing a GP and allow more people to have an effective and abortive treatment for their migraines.”
The Schedule 3 change will see Relpax® Migraine (eletriptan) available in a small pack (maximum two tablets) without a prescription. Schedule 4 larger packs (40 & 80mg) will still be available and will require a prescription. Relpax® Migraine should be taken as soon as possible after the start of a migraine headache.1 Relpax® Migraine provides migraine relief that begins working in as early as 30 minutes.5,6
To receive Relpax® Migraine, people suffering from acute migraine should discuss their symptoms with their General Practitioner or their pharmacist to learn more about the suitability of this treatment and access to treatment over the counter when experiencing migraine episodes.
Full Consumer Medicine Information can be accessed at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-01350-1
Notes to Editors:
Migraine is a common neurological disorder, characterised by moderate to severe headache and nausea. While there is not currently a cure for migraine, there are treatments and lifestyle changes that can help patients manage their migraine and enjoy a normal life. Migraine attacks can have a number of different symptoms and affect patients in diverse ways. However, there are symptoms that characterise migraine attacks and set them apart from other headache disorders such as tension headache or cluster headache. A migraine can be diagnosed when the pain is one sided, moderate to severe intensity, throbbing or aggravated by movement (i.e., walking, going up stairs). As well as having an associated symptom of nausea, vomiting, photophobia (sensitivity to light) or phonophobia (sensitivity to noise).
About Relpax® Migraine (eletriptan)
RELPAX® Migraine contains the active ingredient eletriptan. It is used for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®;. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, and a variety of over-the-counter consumer products. With more than 38,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter, LinkedIn, Instagram and YouTube.
About Migraine & Headache Australia
Migraine & Headache Australia is the only organisation in Australia that has supported the more than five million Australians affected by headache and migraine for over 20 years. Migraine & Headache Australia is a division of the Brain Foundation.
1 RELPAX®; Migraine Australian Product Information. Date of revision: 19 September 2022.
2 Booth A, et al. Managing migraine with over-the-counter provision of triptans: the perspectives and readiness of Western Australian community pharmacists. PeerJ 2019;7:e8134. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921984
2 Bronwyn J et. al. 2020, Migraine management, Australia Prescriber, Vol 43, No 5, Accessed June 2023
3 Deloitte Australia 2018, Migraine in Australia Whitepaper, Deloitte Access Economics, Canberra, Available at: https://www2.deloitte.com/au/en/pages/economics/articles/migraine-australia-whitepaper.html Accessed June 2023
4 Loder E 2002. Presentation, pathogenesis, and treatment of migraine, Progress in Inflammation Research. Accessed June 2023
5 Sheftell F, et al. Headache 2003;43:202–213. Sponsored by Pfizer Global Research and Development.
6 Stark R, et al. Cephalalgia 2002;22:23–32. Sponsored by Pfizer Central Research