Pain is transmitted to the brain as an electrical stimulus from the peripheral nerves where it is perceived as pain. It is known that sodium entering nerve cells are needed for the transmission of electrical stimuli and therefore transmitting pain signals. Halneuron and its active ingredient, Tetrodotoxin, blocks the sodium entry which diminishes the conduction of nerve impulses along nerve fibers, and as a consequence, relieves pain.
1. Chemotherapy Induced Neuropathic Pain (CINP)
Chemotherapy Induced Neuropathic Pain (CINP) patient population in the US, 5EU and Japan was estimated to be ~2 million cases in 2018 and is projected to grow at a cumulative annual growth rate of 1.1% (Data Monitor March 2018).
CINP is an area of unmet medical need for patients treated with some of the most common cancers. CINP is caused by oral or intravenous chemotherapy given to treat the primary tumor or metastases. Common chemotherapy agents that cause peripheral neuropathy include taxanes (paclitaxel and docetaxel), platinum-based drugs (cisplatin and oxaliplatin), vinca alkaloids (vincristine), thalidomide, and proteasome inhibitors (bortezomib). CINP can begin after the first dose of chemotherapy and is often related to cumulative dose. CINP manifests in hands, feet, and sometimes face and can extend in a glove and stocking distribution to affect lower arms and lower legs. The pain is typically of pricking or burning character and may be described as an “electric sensation”.
CINP is a major limitation on the amount of chemotherapy that can be administered to treat cancer and can seriously impact day-to-day function often progressing to a painful disabling condition, causing significant loss of function and quality of life.
There are currently no approved pain therapies for CINP.
2. Cancer Related Pain
The global cancer pain market was valued at ~$5.3 billion in 2017, and is projected to grow at a cumulative annual growth rate of 4.5% from 2018 to 2025 (Allied Market Research December 2018).
Cancer pain is chronic in nature and results from tissue damage, either due to the disease itself, or due to different treatments such as chemotherapy, radiotherapy, or surgery.
While there is a lack of effective alternatives currently available to treat cancer related pain, opioids are currently the most widely prescribed for patients with moderate to severe staged cancer. The demand for cancer pain drugs and especially non-opioid pain medication, is expected to exhibit significant growth in line with a projected increase in the prevalence of cancer globally and continued unmet needs for the management of cancer pain.
3. Burn Pain
According to the American Burn Association, over 450,000 serious burn incidents occur each year. A burn is damage to body’s tissues caused by heat, chemicals, electricity, sunlight or radiation. Symptoms include pain, increasing with each degree of burn, red and swollen skin, blisters and charred and blackened skin. The severity of burn wounds varies, but pain is universal and is especially painful in 2nd and 3rd degree burns.
Burn wounds produce excessive pain during treatment, which can have a profound impact on the quality of life and rehabilitation. Current management of severe burn pain, both in military and civilian populations, is primarily through the systemic delivery of opioids, causing unintended and adverse side effects including cardiac and respiratory depression, and decrease in motor and cognition function. Extended opioid use is often necessary for patients with severe burns and can lead to tolerance, opioid-induced hyperalgesia, and dependence.
Results from a rat model of burn pain suggest that Halneuron and TTX could be developed as an effective, rapidly acting analgesic for civilian and military burn injuries.