Jaleva Confirms Regulatory Route for RelievaDrop Nicotine Replacement Therapy Product

SAN DIEGO, CA, October 8, 2011 – Jaleva Pharmaceuticals LLC is pleased to announce that the FDA has confirmed the regulatory pathway for RelievaDrop, Jaleva’s proprietary transbuccal Nicotine Replacement Therapy (NRT) product currently under development.  The FDA confirmed that the pathway for RelievaDrop is a 505(b)(2) new drug application – subject to the expected bioequivalence/efficacy trials for the transbuccal route of administration.

This confirmation came several months after Jaleva’s scientific advice meeting with the MHRA, the UK regulatory agency.  At that meeting the MHRA confirmed that RelievaDrop would be a MAA under article 10 of the relevant EU Directive.  This MAA regulatory pathway does not require extensive non-clinical and clinical studies as required for a new active substance.

In addition, the MHRA provided their feedback and confirmed that the proposed trials were acceptable for eventual MAA approval if their outcome was positive.

“We are very excited about the recent responses from the FDA and MHRA,” said Mordy Levine, Jaleva’s CEO.  “Given the relatively short regulatory pathways, this product has the opportunity to be on the market in Europe within the next 24 months and thereafter in the US.“

Recent preliminiary pharmacokinetic (PK) data indicate that Jaleva’s investigational product achieved a Nicotine Tmax (time of maximum concentration) of 10 minutes, with the other critical PK values being bioequivalent to Nicorette Lozenge.   In addition, the PK values of Nicotine absorbed from RelievaDrop closely mimic those of a cigarette.

Jaleva’s RelievaDrop has the potential to become the only NRT with a Tmax of less than 10 minutes.  Nicotine gums and lozenges can take up to 30 minutes to maximize delivery of nicotine to the bloodstream.
Jaleva anticipates that by placing one small drop of RelievaDrop on the inside of the cheek, using a unit-dose applicator, it will be likely to achieve very rapid absorption of nicotine into the bloodstream.

“When a smoker trying to quit experiences a craving, they do not want to wait 30 minutes for a gum or lozenge to kick in.  They want relief immediately so they won’t feel the urge to light another cigarette. RelievaDrop has the potential to provide that relief,” said Eva Beim, CMO and Co-founder of Jaleva.

“And unlike gums or lozenges that have to be chewed or sucked for 20-30 minutes throughout the day, RelievaDrop is quick to apply and is quickly absorbed,” said Alex Battaglia, MD, PhD, Jaleva’s President, Chief Science Officer and Co-founder.

Plans for human phase 1 PK trials are underway as are plans for submitting an Investigational New Drug (IND) application to the FDA.

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. In addition to RelievaDrop, Jaleva is developing formulations that treat other Central Nervous System conditions.  The Company is also developing superior topical formulations that are under investigation to treat arthritis, skin cancer, psoriasis and other dermatological conditions.  Unlike any other technology, Jaleva’s patented resin delivery system provides very quick delivery of medication into the bloodstream and also maximizes delivery of active ingredients into the skin.

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

10-08-2011