Hi all,
I know the drug "Lasmiditan" has had a mention or two on the board before, possibly referred to by it's candidate drug number, whilst in early development stages. It has been looked at for further development in the last couple of years and I have been following it's progress with interest.
I should posthumously thank Barry T Coles for first making me aware of the "Ditans" as a drug group and before he departed, encouraging me to follow up on their development. The idea of a "highly selective 5-HT(1F) receptor agonist without vasoconstrictor activity" seemed rather appealing to both Barry and myself.
The promise of daily relief...ahhh...
With so many potential drugs falling over at trial phase 2, like the CGRP receptor antagonists, it's good to see a new one get regulatory approval and show up on shelves.
I am aware that thus far, only Migraine is mentioned in the literature and that there are side-effect issues and adverse outcomes to be overcome, as with any drug.
For those who know and understand the story behind Sumatriptan and how it came to be used in Cluster Headache, those same people with the experience and vision to look beyond the term "Migraine" may see the potential in this drug for CH and also, the appeal of possibility.
2011-2012 literature showed a couple of inconclusive trials that required "Further assessment" of the drug.
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A more recent evaluation:
Quote:Summary
Future Neurology
November 2013
Vol. 8, No. 6, Pages 631-638 , DOI
Drug Evaluation
Lasmiditan for acute migraine treatment
Lars Neeb1 & Uwe Reuter*1
"Lasmiditan is a new neurally acting antimigraine drug that acts as a highly selective serotonin1F receptor agonist. Its chemical structure is distinctly different from that of triptans. Its dose-dependent clinical efficacy was proven in two clinical Phase II trials using intravenous and oral formulations. Oral lasmiditan showed significant headache relief after 2 h at doses of 50, 100, 200 and 400 mg. Adverse events of lasmiditan were dose-dependent and mainly associated with the CNS. They predominantly included dizziness, paresthesia and fatigue, and were mostly mild-to-moderate in intensity. Preclinical studies showed that, unlike triptans, lasmiditan lacks any vasoconstrictive activity, which makes it a promising drug for patients with contraindications to triptans owing to cardio- or cerebro-vascular diseases, or an elevated vascular risk profile."
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Lasmiditan appears to have shown up in South Korea and South East Asia, meaning it must have met some form of regulatory approval and may possibly be available for import. If it has hit shelves there, it may also be sought for import by prescribing specialists for "off-label", "experimental", or on the grounds "compassionate use", in cluster headache.
Just this past few weeks, this press release shows that the drug may have hit some shelves in South East Asia.
Quote:CoLucid signs distribution and supply agreement with ILDONG for Lasmiditan
Published on October 23, 2013 at 12:30 AM
CoLucid Pharmaceuticals, Inc., and ILDONG Pharmaceutical Co., Ltd., announced today that they have entered into a distribution and supply agreement for Lasmiditan in South Korea and Southeast Asia.
Under the terms of the agreement, CoLucid will receive upfront and milestone payments in addition to consideration for product supply in exchange for exclusive rights to ILDONG for development and commercialization of Lasmiditan in the territory. ILDONG will be responsible for the costs and activities related to development and regulatory approvals in the territory and will also participate in key registration trials as part of the global development plan.
"We are very happy to announce the collaboration with ILDONG. We look forward to working together with such a strong partner to bring Lasmiditan to the market to meet the many unmet needs of migraine sufferers," said Thomas P. Mathers, CEO of CoLucid.
ILDONG Pharma Chairman and CEO, Jung-chi Lee, Ph.D., commented, "We expect CoLucid's innovative drug, Lasmiditan, to be successfully developed under our partnership and be subsequently well positioned to perform in the Korean market and Southeast Asia in the near future. We are sure that this will provide us a further opportunity to strengthen the relationship between our two companies."
SOURCE CoLucid Pharmaceuticals, Inc; ILDONG Pharmaceutical Co., Ltd.
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Whether or not this one falls over, nobody will know.
Whether or not it is even appropriate for use in CH, we do not yet know. I have noted the so far, variable dose range in relation to outcomes in Migraine relief and also that aside from oral forms, an intravenous form may be available.
It would be nice to see if an auto-injector whack of this stuff at the correct dose has as beneficial effect as Imigran/Imitrex, without all the issues associated with the vasoconstrictive side-effects of Sumtriptan.
Lasmiditan, if successful, would finally help to rule in or out the long-held belief in "Vascular theory" in headache disorders...
I will post for the site on any case studies, any trials, or any recorded use of Lasmiditan in CH. I cannot yet locate them, but I will post Product Information sheets (PI) and Consumer Medical Information data sheets (CMI) on Lasmiditan when and if they become available.
Cheers, Ben.
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