Sumatriptan

Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·

322822007

Articles

Medicine Compliance Aid Stability

generic · Non-proprietary

Non-proprietary
generic
Tablets 50mg, 100mg
A2 · Amber 2 · No 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 storage conditions.
11th May 2015

Imigran · GlaxoSmithKline UK

GlaxoSmithKline UK
Imigran
Tablets 50mg, 100mg
A2 · Amber 2 · No 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 storage requirements
11th May 2015

Imigran Radis · GlaxoSmithKline UK

GlaxoSmithKline UK
Imigran Radis
Tablets f/c 50mg, 100mg
A2 · Amber 2 · No 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 storage requirements
11th May 2015

Lactation Safety Information

Limited published evidence of safety
Small amounts in breast milk
5HT1-receptor agonist for treatment of acute migraine

New Medicines

ONZETRA Xsail · Migraine - nasal powder

Information

ONZETRA Xsail
New formulation
OptiNose UK
Avanir

Development and Regulatory status

None
Phase III Clinical Trials
Launched
01. Nov 14: The FDA has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825 raising questions regarding the human factor validation study data submitted as part of the NDA. Although the NDA review is ongoing, Avanir has concluded, at this time, that approval of AVP-825 may be unlikely by the PDUFA date of November, 26, 2014. [4]
02. Jun 15: A NDA for AVP-825 has been accepted and is currently under review by the US FDA with a Prescription Drug User Fee Act (PDUFA) goal date of Nov 2015 [5].
03. Jan 16: FDA approval received 28th Jan [6].
04. Jan 16: Approved in US for the acute treatment of migraine with or without aura in adults [7].
05. May 16: Launched for migraine in US [8].
06. Dec 18: OptiNose receives written notice from Avanir Pharmaceuticals of its election to terminate the license agreement to develop and commercialise sumatriptan intranasal powder in the US, Canada, and Mexico. Upon termination of the license agreement in Mar 19, Optinose may elect to continue to commercialise sumatriptan intranasal powder itself or through a new licensee [10].
07. Jan 19: In its 2018 annual report, Optinose does not report plans for licensing in Europe; assume none at present [11].

Category

Serotonin 1D receptor agonist. A powder formulation which is administered using a Breath Powered™, OptiNose device.
Migraine affects about 6% of men and 18% of women [2]
Migraine - nasal powder
Intranasal

Trial or other data

01. Jun 14: The Compass study is a multicenter, randomized, double-blind, double-dummy crossover study in which migraine sufferers were treated with either 22 mg of AVP-825 and placebo tablet or Breath Powered device-delivered placebo and 100 mg sumatriptan tablets. Study participants were instructed to treat up 5 migraine attacks in each 12-week treatment period. 275 participants and 1531 migraines were assessed during the study. The primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30) was met; migraine sufferers achieved greater pain relief within 30 mins of treatment with 22 mg of AVP-825 compared with 100 mg sumatriptan tablet (p<0.0001). AVP-825 treated migraine sufferers achieved pain freedom in a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes post dose compared with those treated with sumatriptan tablet (p<0.05). [1]
02. Nov 14: Results for the TARGET multicenter, double-blind, placebo-controlled PIII study announced; 230 migraine sufferers were randomized to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate to severe migraine pain. Relief of moderate or severe migraine headache were demonstrated as quickly as 15 minutes (19.4% AVP-825 vs. 14.4% placebo device) in subjects receiving AVP-825). A significantly greater proportion of AVP-825 pts reported headache relief at 30 minutes (41.7% vs. 26.9%, P=0.03) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%, P=0.002). Relief was sustained through 24 and 48 hours in a greater proportion of patients who received AVP-825 vs. placebo. The treatment was well tolerated with a low incidence of adverse events (AEs), with the most common AEs being product taste (22%), nasal discomfort (13%), and rhinitis (3%); local AEs were transient and almost exclusively mild to moderate in severity. [3]
03. Jun 15: Results from the PIIIb COMPASS study have been has been published and are available in hard copy at the 57th Annual Scientific Meeting of the American Headache Society (AHS). Pts treated with AVP-825 achieved pain relief and freedom in significantly more migraine attacks at all time points from 15-90 minutes post-dose vs. sumatriptan tablets; at 15 mins (27.9% and 20.9%), at 30 mins (53.8% and 38.7%), at 60 mins (72.1% and 62.6%), at 90 mins (77%% and 72%) and at 120 mins (79.6% and 76.9%) in the AVP-825 and 100mg sumatriptan gps respectively. AVP-825 and sumatriptan tablets achieved sustained pain relief and pain freedom at 24 and 48 hours in a similar number of attacks. The % of migraine attacks with pain freedom at various time points was; at 15 mins (7.2% and 3.7%), at 30 mins (18.2% and 10.8%), at 60 mins (41.2% and 32.9%), at 90 mins (52.8% and 44.9%) and at 120 mins (60.4% and 56.3%) in the AVP-825 and 100mg sumatriptan gps respectively. In addition, AVP-825 treated pts experienced early resolution of all migraine-associated symptoms of nausea, sensitivity to sound and to light in more attacks compared with sumatriptan tablets. The overall safety profile of AVP-825 was consistent with that observed in previous trials with no serious adverse events. Nasal discomfort and product taste were the most commonly reported adverse events, occurring more frequently in the AVP-825 treatment group. Adverse events were mostly mild and transient. Atypical sensations, sometimes called "triptan effects" were significantly less frequent among pts treated with AVP-825 compared with sumatriptan tablets (2% and 5%, respectively; p=0.02) [5].
04. Nov 17: Avanir Pharmaceuticals initiates a PIII trial to assess safety and efficacy of sumatriptan nasal powder in 420 adolescent patients with acute migraine with or without aura in the US (NCT03338920) [9].