Nastech Pharmaceutical Company Inc announced positive results of Nastech's investigational nasal dosage form of sumatriptan for treatment of migraine pain. The study was designed to compare Nastech's investigational nasal formulation against nasal and oral formulations of the marketed product, Imitrex.

Nastech's investigational formulation showed a significantly higher peak concentration and almost double the amount of the active ingredient sumatriptan in the blood during the first 20 minutes compared to the marketed nasal product (both comparisons p < 0.05). This fast absorption is critical for relief of migraine pain, because as reported in the medical literature, the faster blood levels are achieved and the higher the peak plasma levels, the greater the overall migraine pain relief. No serious adverse events related to study drugs were reported. Non-serious adverse events were mild and resolved without medical intervention and with no lasting effects.

The non-blinded Phase I crossover, pharmacokinetic, safety and tolerance study involving 12 healthy male volunteers ages 18 to 50 was conducted at Nastech's Clinical Pharmacology Research Unit at Stony Brook Medical Park in Stony Brook, New York. The study was designed to evaluate the bioavailability of four different formulations of sumatriptan: a single 5 mg dose of Imitrex Nasal Spray, a single 20 mg dose of Imitrex Nasal Spray, a single 25 mg dose of Imitrex oral tablets, and a single 5 mg dose of Nastech's investigational nasal formulation over a four hour period by measuring blood levels of sumatriptan.

Nastech's investigational formulation showed a higher peak concentration and almost double the amount of sumatriptan in the blood during the first 20 minutes compared to the 5 mg marketed nasal product. Both comparisons were statistically significant at p < 0.05. Nastech's investigational 5 mg intranasal dosage form of sumatriptan had a mean time to half-maximum concentration of less than 5 minutes and a time to maximum concentration (Tmax) of 14 minutes. This compares to a mean time to half-maximum concentration of 45 minutes for the marketed 5 mg dose of Imitrex Nasal Spray, 45 minutes for the 20 mg dose of Imitrex Nasal Spray and about 60 minutes for the 25 mg dose of the Imitrex oral tablet formulation. All the formulations were well tolerated and no nasal irritation was observed during the study. Additionally, the subjects reported that Nastech's nasal spray formulation had a significantly reduced medicinal taste than either the 5 mg or 20 mg nasal formulations of the marketed product.

"Migraine is a debilitating condition with considerable impact on the quality of life of sufferers and their families," stated Steven C. Quay, Chairman, President, and Chief Executive Officer of Nastech. "It has been reported in the medical literature that the faster blood levels are achieved and the higher the peak plasma levels, the greater the overall migraine pain relief. Additionally, clinical trials have demonstrated that the medicinal taste of the triptan class of drugs is a significant deterrent to patient compliance, especially with children."

Imitrex Nasal Spray, marketed by GlaxoSmithKline, is an effective treatment for migraine. However, it has been reported that more than 85 percent of the nasal dosage form is absorbed via the gastrointestinal route, subjecting the drug to first pass metabolism and delaying the onset of pain relief. Thus, only a small amount of Imitrex Nasal Spray is absorbed by the nasal mucosa.

Sumatriptan is a member of the selective serotonin receptor agonist family of drugs used to treat migraine headaches. Sumatriptan works by stimulating serotonin receptors in the brain. Sumatriptan, marketed worldwide by GlaxoSmithKline under the brand name Imitrex, is available in injection, nasal spray, and oral tablet dosage forms.