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Pain-Reducing Combination Therapies Proving Successful thanks to Innovative, Specialty Pharma Players

Combination therapies that use cannabis-based pain reduction methods without the negative side effects of opioids are looking to be a positive growth opportunity among specialty pharmaceuticals, particularly for postoperative and chronic pain relief. Leading specialty pharma companies such as India Globalization Capital, Inc. (NYSE: IGC) (IGC Profile), Cara Therapeutics, Inc. (NASDAQ: CARA), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), and INSYS Therapeutics, Inc. (NASDAQ: INSY) are tirelessly working to expand combination therapeutics product lines, while Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) developing an opioid alternative drug intended to reduce pain after surgery.

To date, it is estimated that the annual national cost of pain is between $560 billion and $635 billion – more than priority health conditions among the nation. Sadly, the treatment of postoperative pain remains a daunting challenge for health care professionals, leaving patients debilitated in ways that can affect their daily functioning and, in turn, have a significant impact on our nation’s overall productivity. At present, patients face a significant disadvantage when using opioid drugs to treat postoperative and chronic severe pain, and usage thereof can lead to impactful side effects such as nausea, hallucinations, respiratory depression, constipation, and sedation.

While opioids have been widely accepted as a standard therapy to treat acute post-operative pain, the frequent adverse effects and burden of the cost of care has proven to be a barrier for patients who are unable to receive optimal dosing or adhered to their prescribed treatment. The administration of two opioids is not usually recommended as a treatment for moderate to severe acute pain; however, cannabis-based combination therapies present a unique opportunity in the health sector. Cannabis pharma company India Globalization Capital (IGC) has carved an impressive course in the combination therapy market as a “first mover” to combine existing drugs with cannabis. IGC recently filed a patent for a formulation that the company claims will reduce the side effects of single drugs by combining them with a cannabinoid. In particular, IGC has filed for a provisional patent for the treatment of several eating disorders that uses a combination of compounds and cannabis extracts. The combo therapy is ear-marked for both veterinary and human consumption.

After three years of building a sturdy IP portfolio, IGC is now set to obtain funding to begin both pre-clinical and clinical trials for combination therapies, for which it has started reviewing international medical facilities. Fortunately, securing FDA approval for such therapies, which include the treatment of seizures, neuropathic pain and eating disorders, tends to be swifter and less costly than applying for new drug approval. It is the company’s aim to leverage its unique first-mover position and bring its cannabis-based pharmaceuticals to market in a cost-effective and prompt manner.

Meanwhile, Pacira Pharmaceuticals (PCRX), which is collaborating with Trinity Health to develop an alternative approach to opioids for pain management, recently announced positive results for its medication for opioid reduction in a phase 4 clinical trial. During the trial, a pain regimen along with EXPAREL® was tested against a bupivacaine-based pain regimen that involved other drugs in 139 patients who were undergoing knee replacements. EXPAREL, currently used to produce postsurgical analgesia, combines bupivacaine with the DepoFoam® platform to enable the delivery of bupivacaine over a desired period of time, providing significant reductions in pain with up to a 45 percent decrease in opioid consumption.

In the phase 4 clinical trial, EXPAREL achieved statistical significance for its co-primary endpoints for postsurgical pain and opioid reduction, as well as achieved statistical significance for key secondary endpoints. In a press release announcing the results, Pacira said it continues to analyze further secondary endpoints.

Cara Therapeutics (CARA) is also working to change pain management on a fundamental level. Rather than concentrating on improving old compounds, the company is developing a new class of medicine referred to as KORAs – Kappa Opioid Receptor Agonists. This medication is aimed at targeting different receptors in the body to treat pain in an unconventional, yet more effective, manner. Up to now, Cara’s core product has shown favorable results in phase 2 clinical trials for pain relief and does not elicit the usual side effects patients would normally experience when using opioids such as hydrocodone, morphine, and non-steroidal anti-inflammatories.

Two more candidates for combination therapies come from Zynerba Pharmaceuticals (ZYNE). ZYN001 and ZYN002 are both being evaluated in various therapeutic indications at the moment. ZYN001, a pro-drug patch that comprises of THC, is aimed at enabling transdermal delivery via a person’s skin and into their circulatory system. ZYN002, a CBD gel, is the first of its kind and is designed to act as a non-psychoactive cannabinoid. The gel is to be delivered via the skin and absorbed into a patient’s circulatory system. At present, the gel is in phase 2 of clinical development with patients who suffer with osteoarthritis of the knee, refractory epilepsy, and Fragile X Syndrome.

Focused on the development and commercialization of innovative therapies that improve the quality of life of patients, Insys Therapeutics (INSY) is developing a pipeline of products intending to address unmet medical needs and clinical shortcomings of existing commercial products. The Drug Enforcement Agency recently issued a provisional final ruling that is to result in Insys’ SYNDROS™ being placed in Schedule II of the Controlled Substances Act. The product has been designed for chemotherapy patients and is aimed at helping to alleviate vomiting and nausea. It is also aimed at helping AIDS patients suffering from anorexia-type weight loss.

To date, there are some 53 million outpatients and 45 million inpatient surgeries that are performed in the United States annually. These surgeries necessitate drugs for postoperative pain, and more than half of postoperative patients continue to experience poor pain relief.  At present, the therapeutic classes for postoperative pain management involve analgesics such as hydromorphone, morphine, and fentanyl, as well as NSAIDs – non-steroidal anti-inflammatories. Furthermore, the market is awash with injectable opioids that are administered either via epidural, intravenous, intrathecal, or intramuscular. Usually, the injections are administered either by patient-controlled analgesia devices or hospital personnel.

It has been found that the market for effective acute pain management in the form of combined therapies outside of the hospital setting exceeds more than 200 million prescriptions yearly. While products such as opioid analgesic combinations make up the bulk of the market, the products have significant side-effects, including sedations, dizziness, respiratory problems, substance abuse, euphoria, vomiting, and nausea. Hence, there is a vast market for combined therapies that are able to manage acute pain without producing the negative and uncomfortable side effects.

For more information on India Globalization Capital please visit India Global Capital (IGC)

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