Target Market: The entire neuropathic pain market is characterised by high level of unmet need across all indications and across the seven major markets (US, France, Germany, Japan, Italy Spain and UK). This market is anticipated to grow from USD 2.58 billion in 2012 to USD 3.58 billion in 2022 at a CAGR of 3.19%.  Lidocaine patches are indicated for the treatment of post-herpetic neuralgia (PHN), also called post-shingles pain. PHN is the most common complication of herpes zoster (shingles), a condition that affects 1.1M individuals annually in the U.S. Approximately 13% of shingles sufferers over 60 years’ experience PHN. An aging population is expected to drive demand for the product.

Lidocaine patches themselves are a large and growing market opportunity with over $1.4B in annual sales (~$1.1 billion for the 12 months ending June 30, 2015, IMS Health). With Lidoderm patent expiry in 2014 in US and Versatispatent expiry in 2017, companies are actively looking for a differentiator technology that would give them an edge over the generics.

Solution and Opportunity: A system that allows release of lidocaine at a constant rate and can be administered continuously for longer periods of time without causing skin irritation. Our “zero-waste” patches offer a unique edge over commercial generic brands as described below:

• Poor efficiency and Disposal: The nanocomposite patches are highly effective at manyfold lowered doses and with <3% remaining in the patch at disposal verses 97% in commercial patches. With the currently available format and design, a typical lidocaine patch contains 700mg of lidocaine, of which only 2-3% is delivered. So, appropriate disposal is required and needs to be regulated carefully. There is no known antidote for lidocaine overdose.
• Usage frequency and pain management: With our nanocomposite lidocaine patches, prolonged application and hence better pain management will be possible. Due to skin irritation to high drug doses, a commercial lidocaine patch can only be applied for 12 H with a 12 H break.
• Early release: Our patches release much earlier after application than the commercial patches. This is particularly desirable for pain relief in children.
• Extension to other markets: Fast release soon after application would be a very attractive feature for pediatric use, for pain relief in deep skin wounds or even abrasions, during skin grafts. There is evidence now for its potential use in treatment of other neuropathies e.g.  for diabetic foot ulcers or for other types of chronic pain e.g. arthritis. Lidocaine patches are commonly used for pain relief in veterinary health, e.g. cattle and companion animals. Nanocomposite lidocaine patches would provide a significantly superior alternative to current options.