Nasal Drug Delivery

SNBL’s nasal drug delivery platform is a proprietary system consisting of powder carrier technology and delivery device technology.

Expertise in Nasal Delivery

3D Nasal Cast Model


Results of a Meeting with the US Food and Drug Administration (FDA) Concerning the Development of Intranasal Zolmitriptan for Migraine

Shin Nippon Biomedical Laboratories, Ltd. (SNBL) is currently developing an intranasal formulation of the migraine 1) drug zolmitriptan (development code: TRZ), utilizing SNBL's novel nasal drug delivery system, in the US. Based on the results of the completed Phase 1 study, SNBL held a meeting with the US Food and Drug Administration (FDA) for the development of TRZ until NDA.


The Phase 1 study has already demonstrated that TRZ is safe, and that TRZ is absorbed into the body faster and more efficiently than the marketed zolmitriptan oral tablets and nasal sprays.


At the meeting, SNBL obtained agreement from the FDA for a development pathway of TRZ that is based on pharmacokinetic 2) comparison to existing marketed zolmitriptan products, without the need to conduct large scale clinical studies to demonstrate efficacy of TRZ. SNBL and FDA also reached agreement on the acceptable criteria for pharmacokinetic comparison, as well as development required until NDA.


The above stated agreement on the abbreviated development of TRZ contributes to both the shortening of development period and the reduction of development cost. SNBL will continue to proceed with outlicensing activities for TRZ and the platform technology of nasal drug delivery with pharmaceutical companies.


At the present time, the effect of this matter on the earnings of SNBL's current term is minimal.


* 1 Migraine: Migraine is characterized by a thrusting pain that occurs on either side of the head at the temple; it can also be accompanied by nausea. In severe cases, the pain is sufficient to have a significant impact on the regular lifestyle of patients. In the US, 28 million people (around 10% of the entire population) suffer from migraine headaches, while there are 8.4 million patients in Japan. The majority of migraine patients are between 20 and 40 years of age - at the height of their professional and personal lives - and these patients often live in fear of the next strong migraine attack. Unmet needs remain among patients for a migraine drug with quick and consistent action that is also portable and easy to use.


* 2 Pharmacokinetics: Pharmacokinetics is the way the body acts on the drug once it is administered.The four processes involved are absorption, distribution, metabolism and elimination.