| Indication | Acute or recurrent lower back pain |
| Target Population | 31+ million patients |
| Description | Lidocaine adhesive patch |
| Dosage and Administration | Once daily |
| Adverse Reactions | Mild, transient sensitivity |
| Experience | Over 720 patients treated in five clinical trials |
-
LidoPAIN® BP Placebo-Controlled Dose-Response
Description
LidoPAIN BP is a prescription analgesic non-sterile patch designed to provide sustained topical delivery of lidocaine for the treatment of acute or recurrent muscular skeletal lower back pain of moderate severity of less than three months duration. The LidoPAIN BP patch is intended to be applied once daily and can be worn for a continuous 24-hour period. The patch’s adhesive is strong enough to permit a patient to move and conduct normal daily activities but can be removed easily.
Stage of Development
EpiCept has completed Phase IIa and Phase IIb clinical trials in the U.S. for LidoPAIN BP that included 242 patients. EpiCept is currently working towards scaling up production of this product candidate in order to commence a pivotal Phase IIb clinical trial in the U.S. during the first half of 2007 that will include at least 300 subjects. This trial will be conducted in close consultation with Endo Pharmaceuticals, with which EpiCept entered into an agreement to commercialize LidoPAIN BP worldwide.