IMX-150 Cream for Diabetic Neuropathy

Exclusion Criteria

• •Currently using any nitrate medications
• •Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
• •Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
• •Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
• •Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
• •History of migraine, cluster or vascular headaches, chronic pain with greater pain intensity than the pain of diabetic neuropathy or other chronic pain condition within the region of the diabetic peripheral neuropathy
• •Amputation of more than one toe per foot
• •Neurological disorder or skin condition that may alter local sensation in the feet
• •History of unstable medical problem, clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study mediation, interfere with the study evaluations, or interfere with the patient's ability to comply with the study
• •History of drug (including cannabinoid) or alcohol abuse within the past year
• •Cognitive or language difficulties that would impair completion of the pain assessment tool
• •Within the past 3 months, have had either a myocardial infarction, uncontrolled hypotension, or uncontrolled hypertension
• •Participated in a study of any investigational drug within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Screening
• •Major abdominal, thoracic or vascular surgery within 6 months of the first dose of study medication
• •Open lesions in the area where the cream is to be applied
• •Fertile patients who are unable or unwilling to comply with the contraceptive requirements during the study period