NuPathe Reports Positive Phase One Results for NP101 Transdermal Therapy for Acute Migraine
NP101 combines NuPathe's SmartRelief(TM) proprietary iontophoretic transdermal technology with sumatriptan, the most widely prescribed treatment for acute migraine in the United States. Sumatriptan is also the active ingredient in IMITREX(R), which is also indicated for the treatment of acute migraine.
The study was a randomized, single-center, single-dose, six-period pilot study to evaluate four SmartRelief(TM) prototypes. The study compared sumatriptan pharmacokinetics and safety following administration of NP101 SmartRelief(TM) prototype patches, IMITREX 50 mg tablets, and IMITREX 6 mg subcutaneous injection. Results of the Phase I study were presented today in a poster presentation at the American Headache Society meeting in Chicago.
In the study, NP101 maintained continual therapeutic dosing levels of sumatriptan an average of four times longer than treatment with the 6 mg injection of IMITREX and up to twice as long as treatment with the 50 mg tablet of IMITREX. NP101 was also generally well tolerated.
"These results demonstrate that NuPathe's transdermal technology can deliver therapeutic drug levels quickly and then maintain those levels over a sustained period of time, which may significantly improve consistency of response and decrease frequency of recurrent migraines in patients," said Steven J. Siegel, MD, PhD, assistant professor, University of Pennsylvania, who presented the results in Chicago. "This controlled delivery option could represent an important alternative for patients who experience gastrointestinal disorders such as nausea and vomiting during their migraine attack."
According to Jane Hollingsworth, CEO of NuPathe, "Patients need better options for treatment of acute migraine attacks. Triptans, which are considered the gold standard in treatment today, are proven to be efficacious, but they often result in inconsistent response, nausea, and recurrent headaches. Through NuPathe's patented transdermal delivery system, NP101 is designed to deliver sumatriptan in a consistent and sustained manner through a patch, significantly reducing the risk of GI problems."
Migraine is a widespread, chronic condition that affects approximately 25 million Americans. The primary symptoms include intense and disabling headache, acute sensitivity to light and sound, nausea, and aura. Some experts estimate that the loss of productivity associated with migraine costs the US economy between $13 and $17 billion each year. (1)
Iontophoresis is a non-invasive process for actively transporting drugs through the skin and into underlying tissue. During iontophoresis charged molecules are propelled through the skin using bi-polar electrical fields. Iontophoretic products have been approved for multiple medical and therapeutic uses.
NuPathe specializes in the development of therapeutics for the treatment of neurological and psychiatric disorders including migraine, Parkinson's disease and schizophrenia. NuPathe's lead product, NP101, uses SmartRelief(TM), the company's novel, transdermal patch technology, to deliver sumatriptan, a widely-used therapy for the treatment of acute migraine. Pending regulatory review and approval, NP101 would be the first ever migraine treatment based on a transdermal patch delivery. Phase I clinical results for NP101 have thus far demonstrated rapid delivery of migraine medication and improved pharmacokinetics compared to current standard of care. For additional information, visit www.nupathe.com.
(1) Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med 1999; 159(8):813-818.
Berry & Company
Kim Angelastro, 212-253-8881
Posted: June 2007