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Who are Cara Therapeutics?
Cara Therapeutics Inc. (Nasdaq CARA), a biopharmaceutical company, are based in Stamford Connecticut. They state their overall mission is to change how acute pain, chronic pain, and pruritus are treated and medicated. Their method is through targeting the body’s peripheral kappa opioid receptors (in the peripheral nervous system).
CR845 is said to have performed well in clinical trials, helping ease moderate to severe pain and pruritus (itch). They also reported their patients didn’t experience the undesirable side effects associated with currently available pain and itch medications.
CR845, (also Korsuva™ and Difelikenfalin) can be given intravenous (IV) or taken orally depending on the needs of the patient and seriousness of the condition. CR701 is their only other medication. It is a cannabis alternative to opioids. It is also for pain relief and will solely be available to take orally. It is still in preclinical trials.
What is CR845?
Their product CR845 was approved by the FDA on June 23, 2017 with Breakthrough Therapy designation. Breakthrough Therapy designation is given when a medicine is for a serious or life-threatening disease and has had positive clinical trials.
The FDA was impressed by Part A of Phase 2 trial which was out of a 4 total trials. The trial met its first endpoint with a 68 percent reduction in pruritus (itch) improvement scores. Also, it met its second endpoint with 100 percent improvement in quality of life domains versus placebo. I.V. CR845, according to Cara Therapeutics, it was well-tolerated throughout the trail.
“Opioid analgesics,” the medicine category CR845 falls into, can work through three different types of opioid receptors–mu, delta, and kappa. The most common opioid analgesic, Morphine, acts largely through the mu opioid receptor found in the central nervous system (CNS). The impact on the CNS offers pain relief but is also associated with many CNS-related side effects, such as “nausea, vomiting, sedation, respiratory depression, and abuse liability.”
Kappas are often called KORAs, Kappa Opioid Receptor Agonists. KORA’s, unlike Mu-opioids, don’t transcend the blood-brain barrier which means they’re able to offer pain relief without the harsh side effects of most pain and pruritus medication.
To avoid these side effects, there has been a push to develop opioids that focus on kappa receptors, found on sensory nerves, immune cells, and the dorsal root ganglion (DRG). The dorsal root ganglion is a cluster of neurons (i.e. a ganglion) in a a dorsal root of a spinal nerve. Through this, they have the potential to induce pain relief without creating the CNS and mu-opioid side effects.”
It does however have risks medical marijuana does not. As an opioid, it has a high addiction possibility. American Society of Addiction Medicine reported, having surpass traffic deaths, drug overdoses are now the leading cause of accidental death in the United States.
According to the Centers for Disease Control and Prevention (CDC), there were 63,632 lethal drug overdoses in 2016. 19,413 of those death were caused by synthetic opioids and 15,469 were related to a heroin, an opiate-based illegal drug. They declared Opioid addiction and misuse is a public health epidemic in the U.S.
With these elevated risks in mind, CR845 stands as a better alternative to morphine but is still an opioid and, as a result, it’s never completely risk-free.
What is C4845 for?
Cara is a company focused on developing a medical solution for moderate to severe uremic pruritus (UP) in chronic kidney disease (CKD) patients who are undergoing hemodialysis. Cara Therapeutics are developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors.
That is quite a mouthful. In order to break down the medical terms, I’m going to focus on individual words. Uremia refers to excessive urea in the blood. Urea is a colorless crystalline compound, and the breakdown product of protein. It is excreted in urine. Urea excess occurs when both kidneys stop working (i.e. renal failure).
Considered severe, Pruritus is the worst itching you can imagine. Pruritus is a common problem for CKD patients, particularly those with end-stage renal failure. Hemodialysis is the machine and overall process of cleaning the patient’s blood. Hemodialysis is necessary when both kidneys are no longer working.