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Articles

Safety in Lactation: Antimigraine drugs

21 October 2020If simple analgesics, e.g. paracetamol and ibuprofen, are insufficient to treat symptoms, sumatriptan is the drug of choice for the treatment of acute migraine. Although…

What is serotonin syndrome and which medicines cause it?

22 May 2020This Medicines Q&A outlines the causes and symptoms of serotonin syndrome and provides examples of medicines with the potential to cause serotonin syndrome.  

Triptans and SSRI or SNRI antidepressants – is there an interaction?

27 March 2019The likelihood of an interaction between triptans and SSRIs/SNRIs resulting in serotonin syndrome is considered in this updated Medicines Q&A.
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Medicine Compliance Aid Stability

MaxaltMerck Sharp & Dohme

Merck Sharp & Dohme
Maxalt
Tablets 5mg, 10mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special requirements for storage.
11 May 2015

Maxalt MeltMerck Sharp & Dohme

Merck Sharp & Dohme
Maxalt Melt
Oral lyophilisates 10mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Unsuitable for MCA as hygroscopic.
11 May 2015

Lactation Safety Information

Sumatriptan
No published evidence of safety
5HT1-receptor agonist for treatment of acute migraine
18 September 2020

New Medicines

RizaportMigraine, treatment

Information

Rizaport
New formulation
Exeltis
Gensco Pharma

Development and Regulatory status

None
Licensed but not launched
Not approved
Aug 20IntelGenx grants Exeltis Healthcare an exclusive license to manufacture and commercialise Rizaport in all EU countries, in addition to Spain as previously agreed. Exeltis plans to launch in at least one major market early in 2021 [8].
Jun 20Following its Type A meeting with the FDA, IntelGenx has clarity from the Agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA [8].
Mar 20FDA issues a complete response letter requesting additional information, but no new bioequivalence study [8].
Jan 20IntelGenx enters into a binding agreement with Orivas for commercialisation of rizatriptan oral film in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway) [7].
Nov 19IntelGenx plans to launch rizatriptan oral film in the US after Mar 2020 [7].
Oct 19FDA assigns PDUFA action date of 26/03/2020 [7].
Sep 19Re-filed in the US [7].
Apr 19US FDA issues a Complete Response Letter (CRL) regarding the resubmitted NDA for rizatriptan. The issues mentioned in the CRL related to the chemistry, manufacturing and controls section of the application. The US FDA requested additional information, but no new bioequivalence study [7].
Dec 18Currently approved in Germany, Span and Luxembourg under decentralised procedure [5].
Dec 18Company found partner for US (Gensco Pharma) [5].
Nov 18US FDA accepts resubmitted NDA for rizatriptan oral film for migraine for review, and assigns PDUFA action date of 01/04/2019 [5].
Oct 18Spain grants national marketing authorisation to Groupo Juste (part of Exceltis Healthcare) for rizatriptan 10mg oral film (RIZAPORT®) for the treatment of acute migraines under the European Decentralised Procedure [5].
Nov 17IntelGenx and RedHill continue to seek partnership opportunities for commercialisation of rizatriptan oral film in the US, Europe, Latin America and other territories [4].
Oct 17Re-filed in US [4].
Apr 17Ministry of Health of Luxembourg approves rizatriptan 5mg and 10mg oral film for treatment of acute migraines under the EDP [4].
Aug 16RedHill Biopharma announces intention to re-submit NDA to US FDA in Oct 17 [4].
Nov 15Under the European DCP, Germany served as the Reference Member State. This authorisation is the first national marketing approval of RIZAPORT™. Marketing authorisation in Luxemburg, the Concerned Member State, is expected to follow. RedHill and IntelGenx intend to continue to work together to obtain national phase approvals in other European DCP territories. RedHill is trying to secure commercialisation partners in Europe, the US and additional territories [2].
Sep 15The German Federal Institute for Drugs and Medical Devices (BfArM) grants marketing approval for RIZAPORT™ for treatment of acute migraines under the European Decentralized Procedure (DCP) [2].
Jun 15RedHill reported that it is awaiting FDA inspection of its raw material source, and subject to a successful audit, a new FDA PDUFA date is expected [3].
Mar 14IntelGenx and RedHill Biopharma submit a response to the Complete Response Letter of the US FDA for the NDA for rizatriptan oral film in acute migraine [4].
Feb 14RedHill Biopharma and IntelGenx receive complete response letter from the US FDA [4].
Jun 13The US FDA accepted for review but followed up with questions rimarily relating to third party chemistry, manufacturing and controls (CMC), and to the packaging and labelling of the product [3].

Category

Serotonin 1B and ID receptor agonist as oral film
Migraine affects about 6% of men and 18% of women and around 80% have associated nausea [1,2]
Migraine, treatment
Oral

Trial or other data

Nov 15Rizaport is an oral fast-dissolving thin (30-50µm) polymeric film formulation of rizatriptan for the treatment of migraine. The thin film does not require water and rapidly disintegrates upon oral administration.
May 12RedHill announces positive results in a pivotal bioequivalence trial. Analysis of results demonstrates that the trial met its specified endpoints and FDA´s criteria, in all parameters for bioequivalence, between RHB-103 oral thin-film, and Maxalt-MLTR. The trial was conducted in Canada following discussions with the FDA and under a CTA (Clinical Trial Application) approval from Health Canada [3].