Changing Healthcare Worldwide


Release issued 04/05/2008

North Palm Beach, Florida


TransDermal Technologies announced today the successful completion of a proof-of-concept trial of its TDS® liquid, fast-acting topical system for Diazepam (Valium®). This success of the TDS Diazepam product represents the first documented instances of Diazepam being successfully delivered through intact skin. Diazepam is currently approved for oral, intravenous, intramuscular, or rectal administration. Diazepam has not been known before this trial to metabolize in the skin and has not been successfully delivered by patch or other topical preparation. The potential market for transdermally delivered Diazepam is expected to exceed $300 Million annually.

The rectal diazepam product is approved for acute intervention by non-medical personnel in patients with epileptic conditions who experience break-through seizures despite their normal daily maintenance oral dose of Diazepam. The product is designed to raise or “top off “the serum concentration of the drug and active drug metabolite desmethyldiazepam to above 10 nanograms per deciliter (ng/dL). Experts in the treatment of seizure disorder agree that when the serum level of desmethyldiazepam falls below 10 ng/dL, seizures tend to present. The rectally delivered product, while effective, is not preferred by care-givers due to the inconvenience of its mode of application which requires waiting for the patient to come out of seizure before dosing and the necessity in a school or training center environment to have another adult present for the dosing. In addition the rectal delivery results in a quite high serum level of Diazepam along with a dose of ethanol from the vehicle which taken together generally result in the patient becoming extremely sleepy shortly after dosing, hindering normal daily activity. The rapid increase in serum drug metabolite to the therapeutic levels required to stop seizure observed with the TDS Diazepam, coupled with the ability to potentially be applied while the patient is still seizing, point to a potentially very interesting therapeutic alternative to the existing rectal modality. The TDS drug formulations and protocol requirements were well tolerated by all subjects in the study. This proof of concept study demonstrates that the TDS preparation successfully delivered diazepam systemically to adults. The TDS Diazepam was trialed against the hydro-alcohol gel formulation delivered trans-rectally with a syringe-and-tube device. As expected, the concentration of diazepam following the TDS application was lower and not bioequivalent to rectal gel. Future development of this unique system will focus on further enhancing the formulation to create a clinically appropriate and preferred alternative to rectal or intravenous diazepam treatments. These results were presented by Dr. Arthur T. Tucker and Dr. Chandan Alam at the winter meeting of the British Pharmacological Society and were received with great interest. The poster is provided as an attachment below.

TransDermal is actively seeking a licensing partner for development of this opportunity. TDS systems are routinely cost-competitive with tablets on a per-dose basis. Recent interaction with the U.S. F.D.A. in pre Investigational New Drug (IND) discussions as well as with the British M.H.R.A. leads the company to expect a clear path forward to approval. The company plans to prepare an IND application for the product and request a pre-IND meeting to review the clinical development plan for TDS Diazepam with FDA in the near future.

For more information contact            

Bill Rowen, Vice President- New Business Development