Naratriptan
Clinical data | |
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Trade names | Amerge, Naramig, others |
AHFS/Drugs.com | Monograph |
MedlinePlus | a601083 |
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Routes of administration | Oral |
ATC code | |
Legal status | |
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Pharmacokinetic data | |
Bioavailability | 74% |
Metabolism | Hepatic |
Elimination half-life | 5-8 hours |
Excretion | Renal |
Identifiers | |
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JSmol) | |
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Naratriptan (trade names include Amerge) is a
It was patented in 1987 and approved for medical use in 1997.[1]
Medical uses
Naratriptan is used for the treatment of the acute migraine attacks and the symptoms of migraine, including severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light.[2]
Efficacy
A meta-analysis of 53 clinical trials has shown that all triptans are effective for treating migraine at marketed doses and that naratriptan, although less effective than sumatriptan and rizatriptan was more effective than placebo in reducing migraine symptoms at two hours[3] and efficacy was demonstrated in almost two thirds of subjects after four hours of treatment.[4]
Side effects
Side effects are similar to other triptan medications, with the incidence of side effects reportedly being lower than sumatriptan, and side effects occurring rarely except when above 2.5mg.
Mechanism of action
The causes of migraine are not clearly understood; however, the efficacy of naratriptans and other triptans is believed to be due to their activity as
Society and culture
In the United States, the Food and Drug Administration (FDA) approved naratriptan on February 11, 1998.[8] It was covered by U.S. Patent no. 4997841; the FDA lists the patent as expiring on July 7, 2010.[8][9]
In July 2010, in the wake of the patent expiration, several drug manufacturers, including
announced that they were launching generic Naratriptan medications.The drug continued to be covered by European patent 0303507 in Germany, Spain, France and the United Kingdom through March 10, 2012,[13] and by Australian patent 611469 in Australia through June 17, 2013.[13] It had previously been covered by Canadian patent 1210968; but both Sandoz and Teva (formerly Novopharm) have offered generic equivalents in Canada since that patent's expiration December 1, 2009.[13]
On December 23, 2014, in response to a request from Health Canada, importers in Canada agreed to quarantine the importation of health products, including generic Naratriptan manufactured for both Sandoz and Teva, from Dr. Reddy's Laboratories in Srikakulam, India.[14][15] Because Teva and Sandoz are the only approved suppliers of generic Naratriptan in Canada, the quarantine resulted in Naratriptan being placed on the Canadian drug shortage list.[16]
Following the Canadian quarantine, the
References
- ISBN 978-3-527-60749-5.
- ^ "Naratriptan". Medline Plus Drug Information. U.S. National Library of Medicine. Retrieved 6 August 2009.
- S2CID 2368571.
- PMID 10972633.
- S2CID 219185675.
- ^ PMID 15992123.
- PMID 17883520.
- ^ a b "Naratriptan Hydrochloride". Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. Archived from the original on 3 March 2016. Retrieved 8 September 2008.
- ^ US 4997841, Oxford AW, Sutina D, Owen MR, "Indole derivatives", issued 5 March 1991, assigned to Glaxo Group Ltd
- ^ DeArment A (2010-07-09). "Roxane launches generic Amerge, Arimidex". Drug Store News. Retrieved 2010-07-23.
- ^ DeArment A (2010-07-12). "Sandoz launches generic Amerge". Drug Store News. Retrieved 2010-07-23.
- ^ DeArment A (2010-07-14). "Teva launches generic Amerge". Drug Store News. Retrieved 2010-07-23.
- ^ a b c Oh D (June 2010). "Drug In Focus: Naratriptan". GenericsWeb. Archived from the original on 2017-01-06. Retrieved 2010-12-15.
- ^ "Health products quarantined from two India sites". Health Canada. Government of Canada. December 24, 2014. Retrieved September 14, 2017.
- ^ "Health products quarantined from two sites in India as Health Canada assesses data integrity concerns". Recalls and safety alerts. Health Canada. December 23, 2014. Retrieved September 14, 2017.
- ^ a b "Dr. Reddy's largest API Facility Maybe the Next to Get Banned from Exporting to the United States". PharmaCompass. LePro PharmaCompass OPC Private Limited. March 30, 2015. Retrieved September 14, 2017.
- ^ "Stop the importation and distribution of Medical Products manufactured by Dr. Reddy's Laboratories in Srikakulam, India & IPCA Laboratories in Pithampur". Health Authority – Abu Dhabi (HAAD). Circular no. HRD/017/15. United Arab Emirates Ministry of Health. 19 February 2015. Archived from the original on 15 September 2017. Retrieved 14 September 2017.