SUD-001 : migraine

SUD-001 is a first-in-class mint-flavoured oral spray formulation of sumatriptan (marketed in tablet form and in a nasal spray by GlaxoSmithKline under the brand name Imitrex®). Sumatriptan is one of the most widely used drugs for the treatment of acute migraine in adults and works by narrowing the blood vessels in the brain.

Two clinical trials have been conducted to evaluate SUD-001. The objectives of the trials were: (1) to determine whether sumatriptan can be absorbed across the oral mucosa, and, if so; then (2) to describe its pharmacokinetics (PKs); and (3) to investigate whether there are pharmacodynamic (PD) correlates of such PKs in patients experiencing migraine attacks.

The first clinical trial included 10 healthy male volunteers in a four-arm, crossover PK study comparing the performance of the SUD-001 (20mg and 30mg in fasting conditions, and 20mg in non-fasting conditions) with the 50mg sumatriptan tablet. The study demonstrated a statistically significantly faster rate of absorption with SUD-001 than tablets and up to a 50% increase in relative bioavailability of sumatriptan. The rate of drug absorption is believed to be predictive of the degree and speed of migraine relief. The initial PKs of SUD-001 approximate to those of a subcutaneous injection.

Although Imitrex® nasal spray was not included in this clinical study, time to the first peak plasma concentration of sumatriptan was approximately 70% faster with the 20mg dose of SUD-001 than has been reported in the literature for the same dose of Imitrex® nasal spray. In addition, the mean concentration level achieved during this critical first phase of absorption was approximately 30% greater for SUD-001 than has been observed in published studies of the nasal spray.

The second clinical trial evaluated efficacy and safety in migraineurs. This was a multi-centre, active control, open-label, dose-ranging study. All dosing was done on an outpatient basis and patients returned to the clinic between migraine attacks.

Subjects received up to five treatments, comprising single doses of the following: sumatriptan 50mg and 100mg tablets, and SUD-001 20mg, 30mg and 40mg oral spray.

In the primary analysis of efficacy, the percentage of patients responding to treatment at or before 60 minutes post-dosing, the 30mg and 40mg dosages of SUD-001 provided a statistically significant greater reduction in headache pain compared to the 50mg tablet (42% and 46%, respectively, vs. 12%; P≤0.011), and were comparable to the higher (100mg) dose of the tablet formulation (42%).

Significantly more patients responded to all three doses of SUD-001 than to 50mg sumatriptan tablet by 90 minutes post-dosing (57% to 70% vs. 32%; P≤0.028), and all three SUD-001 doses were comparable to the 100mg tablet.

Overall, these results indicate that SUD-001 at doses of 30mg and 40mg may be significantly more effective than the 50mg sumatriptan tablet in reducing pain and other symptoms associated with migraine headaches and produce a degree of relief that is qualitatively similar to the 100mg sumatriptan tablet.

Migraine is a painful and debilitating condition that disrupts lives, impacts careers and costs employers in lost work and diminished productivity. According to a 2011 WHO report, migraine affects about 11% of the global adult population and the market value for the same year was estimated to be around US$3.2bn and is forecast to reach US$4.4bn by 2020.

If you are interested to learn more about SUD-001, please email This email address is being protected from spambots. You need JavaScript enabled to view it. (Chief Business Officer).