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Pliaglis™
Pliaglis™ is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to painful cosmetic procedures such as dermatologic laser surgery and dermal filler injections. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes our Peel technology. Pliaglis™ was approved by the FDA in June 2006 and is currently being sold by Galderma in the United States.
Pliaglis™ is applied to intact skin before superficial dermatological procedures. Pliaglis™ should be applied for 20-30 minutes prior to minor dermatological procedures, such as a dermal filler injections, and for 60 minutes prior to major dermatological procedures, such as laser-assisted tattoo removal. Following the application period, Pliaglis™ can easily be removed from the skin and the procedure can be performed.
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Synera®
Synera®, marketed as Rapydan® in Europe, is a topical patch designed to provide local dermal anesthesia for potentially painful superficial procedures, such as venous access procedures involving needles and immunization injections of children. Synera® uses CHADD® technology and a proprietary local anesthetic formulation that contains lidocaine and tetracaine. The CHADD® unit generates gentle heating of the skin and has been demonstrated in a well-controlled clinical trial to contribute to the efficacy of Synera®. Synera® was approved by the FDA in June 2005 and in Sweden in January 2007.
Synera® resembles a small adhesive bandage in appearance and ease of application, and is applied to the skin before painful medical procedures such as venous access, such as blood draws and catheter insertions needle injection and minor dermatologic surgical procedures. To apply, the patch is simply removed from its pouch, peeled from a plastic liner and applied to the skin. Synera® is applied for 20 to 30 minutes prior to venous access procedures and needle injections and for 30 minutes prior to minor dermatological procedures such as shave biopsy and excision.
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ThermoProfen™
ThermoProfen™ is a matrix transdermal ketoprofen patch that is integrated with a long-lasting CHADD® unit to assist in the local delivery of the drug and to provide therapeutic heat. It is designed to treat chronic pain associated with osteoarthritis (OA) of the knee. ThermoProfen™ will be evaluated for once-per-day, 12-hour application. We believe ThermoProfen™ can provide localized pain relief with lower systemic levels than oral administration of ketoprofen, which we expect will reduce the frequency of adverse effects of oral ketoprofen and other oral NSAIDs.
As a new topical treatment for the pain associated with OA of the knee, we believe ThermoProfen™ can provide similar pain relief to that provided by orally administered NSAIDs with lower levels of systemic side effects and comparable ease and convenience of use. ThermoProfen™ Phase 1 clinical trials demonstrated that the controlled heat produced by CHADD® increases both the rate of drug delivery and the total amount of drug delivered from these patches. In addition, we expect that the gentle heat provided by the CHADD® heating component of ThermoProfen™ will contribute to the efficacy of the product. Existing over-the-counter products that produce uncontrolled heat, and do not contain any drug, can improve the symptoms associated with OA. We believe that the unique and potentially complementary combination of controlled heat from the CHADD® units and the local, topical delivery of ketoprofen may provide better pain relief than either uncontrolled heat or ketoprofen alone.
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ZS-2001
ZS-2001 utilizes our phase-changing cream (Peel) drug delivery technology combined with a proprietary formulation of lidocaine and tetracaine for the treatment of neuropathic pain. We are conducting a Phase 2 clinical trial that will assess the efficacy of ZS-2001 for the treatment of neuropathic pain.
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Alprazolam Patch
Our transdermal alprazolam patch is being developed to treat panic disorder. We believe this product will deliver alprazolam across the skin at a controlled rate for up to three days, offering the potential for improved patient compliance and product efficacy. The alprazolam patch is currently in Phase 2 clinical trials.
We believe we can develop a product that delivers therapeutic concentrations of alprazolam transdermally into the blood stream for up to three days. Our alprazolam patch is designed to provide benefits over the existing treatment options by: - Delivering more consistent blood levels of alprazolam than oral doses;
- Improving patient compliance and thus product efficacy;
- Having fewer side effects during drug tapering and discontinuation;
- Eliminating the patient’s anxiety of properly timing their dosage observed with oral alprazolam;
- Delaying relapse.
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Local Anesthetic DuraPeel™
Our local anesthetic DuraPeel™ is a phase changing cream designed to deliver a local anesthetic for an extended period of time. The product is being developed for the topical treatment of neuropathic pain.
Our local anesthetic and steroid DuraPeel™ product candidates are initially dispensed as a cream and spread onto the skin, where they dry to form a pliable layer. The underside of this layer delivers a sustained steady-state dose of drug for an extended period. Following the desired application time, the DuraPeel™ layer can be peeled or washed from the skin. We believe the ease of application and duration of delivery by DuraPeel™ will provide increased convenience over the current treatment for hand dermatitis and neuropathic pain. We are currently conducting a Phase 2 clinical trial for our local anesthetic DuraPeel™ and a Phase 1 clinical trial for our steroid DuraPeel™
Steroid DuraPeel™
Our steroid DuraPeel™ is a phase changing cream designed to deliver a steroid for an extended period of time. Our product is being developed for the topical treatment of hand dermatitis.
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