Jaleva Announces Preclinical PK Test Results for ‘RelievaDrop’ Transbuccal Alprazolam and ‘RelievaDrop’ Transbuccal Ondansetron

SAN DIEGO, CA, November 21, 2011 – Jaleva Pharmaceuticals LLC announces pre-clinical pharmacokinetic (PK) results for two of its formulations, RelievaDrop Alprazolam and RelievaDrop Ondansetron. Both are in the family of Jaleva’s quick relief products currently under development.

BioTox Sciences CRO has completed a series of pre-clinical pharmacokinetic (PK) trials measuring the levels of each of these two active ingredients in the blood serum of canines after buccal administration of RelievaDrop Alprazolam and RelievaDrop Ondansetron. These trials showed that Jaleva’s investigational product achieved a Tmax (time to achieve maximum concentration) of 6 minutes for Alprazolam and 18 minutes for Ondansetron.

By applying one drop of RelievaDrop (with an active ingredient) on the inside of the cheek, using a unit-dose applicator, it achieves very rapid absorption of the active ingredient into the bloodstream.
Alprazolam (trade name: Xanax) is used to treat treat anxiety disorders and panic disorder. Ondansetron (trade name: Zofran) is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. The Tmax for the Alprazolam tablet is 60-120 minutes. The Tmax for the Ondansetron tablet is 90 minutes.

The rapid Tmax for RelievaDrop Alprazolam and RelievaDrop Ondansetron position them as ideal candidates for quick relief from these conditions. Injection or intravenous administration of these drugs may be the only other delivery mechanism providing immediate relief. In addition, injection or intravenous delivery requires administration by a clinician in a hospital or medical setting.

Plans for human phase 1 PK trials are underway for submitting an Investigational New Drug (IND) application to the FDA, as well as the comparable application to the MHRA in the United Kingdom.

“When a patient experiences an anxiety or panic attack, waiting 1 – 2 hours for their Xanax to provide a therapeutic effect, can seem like forever. Patients want relief as soon as possible under these difficult circumstances, and RelievaDrop Alprazolam has the potential to provide that relief,” said Eva Beim, CMO and Co-founder of Jaleva. “When patients undergo chemotherapy, 90 minutes is a long time to wait for a reduction in post-chemo nausea. RelievaDrop Ondansetron has the potential to provide patients with a product that can reduce their nausea in 18 minutes – truly fast relief.”

“Jaleva was able to confirm once again that the RelievaDrop delivery technology is an excellent way to deliver active ingredients to the bloodstream – given the short Tmax we have seen with our formulations time and time again. We are encouraged by the results and firmly believe that the quality of life for thousands of patients can be improved with RelievaDrop delivery,” said Alex Battaglia, MD, PhD, Jaleva’s President, Chief Science Officer and Co-founder.

“We are excited because we have been able to confirm a short Tmax in delivering active ingredients into the bloodstream on a consistent basis using our unique and easy to use resin technology. To my knowledge, there is no other delivery system that can achieve this fast delivery. RelievaDrop is quick and easy to apply,” said Mordy Levine, Jaleva’s CEO.

Formed in 2003, Jaleva Pharmaceuticals LLC is a privately held company. Jaleva is engaged in the research & development of resin-based vehicles that quickly deliver medications trans-mucosally to the bloodstream. Jaleva is developing formulations that treat such conditions as smoking cessation, anxiety, chronic breakthrough pain and migraines. The Company is also developing superior topical formulations that are under investigation to treat arthritis, skin cancer, psoriasis and other dermatological conditions.

For inquiries contact: Mordy Levine, CEO, 561–573–0094.

11-21-2011