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Allodynic Therapeutics is a clinical stage bio-pharmaceutical company focused on the development of products for treatment of pain. Allodynic Therapeutics is dedicated to improving the lives of those affected by pain with the ambitious goal of ending pain as we know it.  Allodynic’s product candidate (ALLOD-2) is been developed first, for the indications of: the acute treatment of episodic migraine, prevention of episodic migraine, and chronic low back pain. ALLOD-2 is potentially useful for treatment of various neuropathic pain conditions, such as: trigeminal neuralgia, postherpetic neuralgia, fibromyalgia, vulvodynia, diabetic peripheral neuropathy, exc.

Allodynic’s product candidate is a combination of two re-purposed marketed drugs used for the treatment of pain due to discovery of biologically and clinically relevant affinity for new targets. Both drug are being re-purposed at a significantly lower dosage compared to the maximum dosage that has already been approved for the marketed indications.

The product blocks innate immune system activation that leads to neuroinflammation and pain.  The product dually blocks proinflammatory cytokines release[nitric oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and activation of COX-2.

Allodynic Therapeutics was founded by Annette C. Toledano, M.D., a practicing Internist from Miami. She was motivated to develop an effective and non-narcotic treatment for pain by her inability to find an effective treatment for her own back pain. The United States Food and Drug Administration (FDA) granted a “Breakthrough Designation” for ATNC05 in 2013. ATNC05 is a product which was developed by Allodynic prior to developing ALLOD-2. ALLOD-2 shares one component with ATNC05.  Allodynic’s Pilot study data, indicate ALLOD-2 is superior to ATNC05.

Dr. Toledano is currently conducting four investigator – initiated clinical trials for the following indications:

1. Acute Migraine (two studies),
2. Migraine Prevention,
3. Chronic Low Back Pain.

LIst of clinical trials can be found at: https://clinicaltrials.gov/ct2/results?cond=&term=ALLOd-2&cntry1=&state1=&recrs=

1. Oral ALLOD-2 vs. Components and vs. Placebo in the Acute Treatment of Migraine (ANODYNE-1)
2. Oral ALLOD-2 vs. Oral Sumatriptan and vs. Placebo in the Acute Treatment of Migraine With Associated Nausea (ANODYNE-2)
3. Efficacy, Safety, and Tolerability of Twice Daily Oral ALLOD-2 vs. Placebo in Episodic Migraine Prevention (ANODYNE-3)
4. Twice Daily Oral ALLOD-2 vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)
5. Efficacy of ATNC05 in Reducing Back Pain Compared With Placebo

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