Early Stage Pain

In addition to Pennsaid and Pennsaid 2%, Nuvo is developing topical pain medications for a variety of pain conditions, including pain of inflammatory, nociceptive and neuropathic origin. All of these pain medications are being designed to treat the pain locally while limiting systemic exposure to the active drug; thereby, reducing the potential for negative side effects, adverse events and potential drug-drug interactions. The drug product candidates under development are at various stages of preclinical development.

In June 2011, the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application filed May 27, 2011 for a novel topical Lidocaine Spray formulation (NRI-ANA), allowing for initiation of Phase 1 studies. NRI-ANA is a novel, spray formulation of lidocaine designed to allow application of the product without the need to touch the skin. Patients with neuropathic pain often suffer from allodynia, a common disabling symptom in which normally non-painful touch can result in pain. A spray formulation may be advantageous in certain patients as the drug can be delivered without the need to touch the skin, leading to a more comfortable experience and potentially enhanced compliance. The product currently has international patents pending.

Nuvo recently announced an agreement to acquire ZARS Pharma Inc. and in addition to the approved products, Synera and Pliaglis, ZARS has several early stage products and technologies.  In the area of pain, Flexicaine™ is a dermal analgesic cream which combines Peel technology with a proprietary formulation of lidocaine and tetracaine to safely and effectively anesthetize larger, contoured areas of the body.

The Company continues to actively seek to expand its pain pipeline by acquiring or in-licensing clinical stage pain assets to provide a more balanced portfolio of products under development and a new series of inflection points for prospective and current investors.