Pressure-Assisted Auto Injectors
A significant challenge beyond discovery of new molecules is how to effectively deliver them by means other than conventional needle and syringe. The majority of these molecules have not, to date, been amenable to oral administration due to a combination of several factors, including breakdown in the gastrointestinal tract, fundamentally poor absorption, or high first pass liver metabolism. Pressure assisted auto injection is a form of parenteral drug delivery that continues to gain acceptance among the medical and patient community. Encompassing a wide variety of sizes and designs, this technology operates by using pressure to force the drug, in solution or suspension, through the skin and deposits the drug into the subcutaneous tissue.
We have designed disposable, pressure assisted auto injector devices to address acute and chronic medical needs, such as rheumatoid arthritis and psoriasis, allergic reactions, migraine headaches, acute pain and other undisclosed therapies. Our proprietary VIBEX® and QuickShot® disposable auto injector systems combine a spring-based power source with a shielded needle, which delivers the needed drug solution subcutaneously or intramuscularly. In order to minimize the anxiety and perceived pain associated with injection-based technologies, the VIBEX® and QuickShot® systems feature a triggering collar that shields the needle from view. The patented retracting collar springs back and locks in place as a protective needle guard after the injection, making the device safe for general disposal. In clinical studies, these devices have outperformed other delivery methods in terms of completeness of injection and user preference, while limiting pain and bleeding.
- Rapid injection
- Eliminates sharps disposal
- Ease of use in emergencies
- Reduces psychological barriers since the patient never sees the needle
- Reliable subcutaneous or intramuscular injection
- Designed around conventional pre-filled syringes
The primary goal of the VIBEX® and QuickShot® disposable pressure assisted auto injector platforms is to provide a fast, safe, and time-efficient methods of self-injection. These devices are designed around conventional single dose pre-filled syringes, which is a primary drug container, offering ease of transition for potential pharmaceutical partners. We have signed two license agreements with Teva for our VIBEX® system. One of these agreements is for a product containing epinephrine and the other is for sumatriptan. We also developed the VIBEX® auto injector system for delivery of methotrexate (OTREXUP™) for treatment of RA, pJIA and psoriasis. Our latest advancement in our proprietary line of VIBEX® auto injectors is the VIBEX® QS auto injector system which offers a dose capacity of 1 mL and greater in a compact design. VIBEX® QS is designed to enhance performance on the attributes most critical to patient acceptance—speed, comfort and discretion. VIBEX® QS achieves these advancements by incorporating a novel triggering mechanism and space-saving spring configuration. The design of the QuickShot® platform also accommodates fast injection of highly viscous drug products that stall less-powerful conventional auto injectors. Many self-injectable biological agents currently marketed and in clinical development are formulated to be administered in a 1 mL dose volume and tend to be of higher viscosity than non-biologic injectable products. We are developing products based on the VIBEX® QS system, including the VIBEX® QS T for delivery of testosterone as replacement therapy in men who have testosterone deficiency, VIBEX® QS M with an undisclosed drug for treatment of a CNS indication, and VIBEX® QS for use with the progestin hormone drug Makena® used to lower the risk of preterm birth.
Disposable Pen Injector System
Our multi-use, disposable pen injector complements our portfolio of single-use pressure assisted auto injector devices. The disposable pen injector device is designed to deliver drugs by injection through needles from multi-dose cartridges. Our disposable pen injector is designed for chronic conditions such as diabetes, which require daily injection of a product. Depending on dose, our pens can hold up to thirty days of drug dosing. We have begun to scale up tooling and molds for potential commercial scale production. Although differing from the other pressure assisted injection strategies common to the above portfolio of injection therapy, this device includes a dosing mechanism design that is drawn from our variable dose needle-free technology. We have signed a license agreement with Teva for our pen injector device for two products: an undisclosed pen device under development for use in U.S. and Europe, and an exenatide pen which has an ANDA under active review at the FDA.
Needle-free injection combines proven delivery technology for molecules that require parenteral administration with a device that eliminates the part of the injection that patients dislike – the needle. Improving patient comfort through needle-free injection may increase compliance and mitigate the problem of daily injections. Needle-free delivery eliminates the risk of needlestick injuries as well, which occur frequently in institutions in the U.S., and can result in disease transmission to healthcare workers. One of the primary factors influencing development in the category of needle-free injection is the inherent problematic dependence on needles. It is also recognized that greater willingness to accept injection therapy could have a beneficial impact on disease outcomes. However, needle-free devices may be commercially limited due to the high cost of the product and the need for consumable disposables.