Drug Makers Focusing on Pain Management Alternatives to Opio

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|Feb 14|magazine29 min read

PALM BEACH, Florida, Feb. 13, 2020 /PRNewswire/ -- Opioid drugs are and have been a God-send for many patients whose severe, excruciating pain had no other drug or device to allow them to escape from its throes… But we all know that the other side of that coin has created a social hell of its own. That is the impetus for the ever increasing non-opioid pain, treatment and device markets efforts to find alternatives and effective replacements for opioids. The global opioid epidemic has escalated at an alarming rate, owing to which several countries have opted for other alternatives for the management of pain. In 2017, opioid crisis was declared as a national emergency indicating the impact of opioid addiction in the U.S. According to data from National Institute of Drug Abuse, an estimated 90 Americans die of opioid overdose every day. The Centers for Disease Control and Prevention estimates that the economic burden brought upon the country because of opioid misuse amounts to USD $78.5 Billion every year. These costs include those incurred for healthcare expenditure, addiction treatment, loss of productivity, and criminal justice involvement. These facts are indicative of the growing need to curb this addiction. Thus, demand for other alternatives that are safe has increased, boosting market growth.  Active biotech and pharma companies in the markets this week include:  Q BioMed Inc. (OTCQB: QBIO), Collegium Pharmaceutical, Inc. (NASDAQ: COLL), Mallinckrodt plc (NYSE: MNK), Endo International plc (NASDAQ: ENDP), Teva Pharmaceutical Industries Limited (NYSE: TEVA).

Pain and related disorders are increasing at a rapid rate globally owing to changes in lifestyle, lack of physical activity, and growing number of surgical procedures. Chronic and acute pain affects more Americans than diabetes, cancer, and heart diseases combined, according to the U.S Department of Health and Human Services (HHS). HHS also reported that pain is the most common reason for visits to healthcare facilities, which makes it the foremost cause of disability in patients, thereby contributing largely to healthcare costs. The aforementioned factors are encouraging the discovery of safe and effective management options such as non-opioid pain patches, thus boosting their market growth.  As a result of these efforts, the non-opioid sub-markets are projected to continue their impressive growth rate well into the future.

Q BioMed Inc. (OTCQB:QBIO) BREAKING NEWS: Q BioMed Launches Non-Opioid Treatment for Metastatic Bone Pain - Q BioMed a commercial stage biotech company, announced today the launch of its FDA approved non-opioid drug Strontium89  (Strontium Chloride Sr-89 Injection, USP), which has been shown in clinical studies to help relieve persistent pain associated with cancer that has metastasized to bone. In several multicenter, placebo-controlled trials in cancer patients with persistent pain after external beam radiation therapy for bone metastases, pain relief occurred in more patients treated with a single injection of Strontium89 than in patients treated with an injection of placebo, with a greater percentage of patients experiencing pain scores of zero without any need for opioid or non-opioid rescue analgesics. Duration of pain palliation has been shown to range from 2 to 5 months in most patients. Strontium89 can be redosed every 90 days.

An estimated 10 million people are living with bone metastases. Due to the opioid crisis, clinicians and patients are looking for pain management alternatives. Strontium89, which is administered every 3 months, has been shown to relieve pain in over 70% of patients who received the treatment. Q BioMed is hopeful that broad market reacceptance will be swift.

Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable.

Q BioMed has already received U.S. hospital orders and will begin delivering doses in February. Q BioMed's contract manufacturing facility is manufacturing initial commercial-scale quantities now; manufacturing will reach full production quantities in March. Under its distribution relationship with Jubilant Radiopharma, Q BioMed has the capability to reach patients in all 50 states. Orders can be placed by calling Jubilant Radiopharma at (901) 345-3434. Commercial and marketing activities, including conferences and sales, will begin concurrently with commercial availability. Strontium89 is reimbursed by Medicare and most insurance companies.

"This is a major milestone for Q BioMed. We are now a revenue-generating entity. This was a goal we set for ourselves when we founded the company almost 5 years ago. The journey to producing this critically important drug has not been easy, but we are now here. It's a great achievement and a testament to all those who have helped get us to this point. We look forward to being able to help serve the unmet needs of the millions of patients suffering from debilitating bone pain associated with metastatic cancer. Years of well-documented data show that Strontium89 can help alleviate the pain suffered by most patients with painful bone metastases. We believe this drug has a very important role to play as clinicians move toward proven non-opioid therapeutics for pain palliation," stated Q BioMed CEO Denis CorinRead this entire release and more news for QBIO athttps://www.financialnewsmedia.com/news-qbio/   

Other recent developments in the biotech industry include:

Collegium Pharmaceutical, Inc. (NASDAQ: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, recently announced that it has entered into a definitive agreement to acquire the U.S. rights to the Nucynta Franchise from Assertio Therapeutics, Inc. ("Assertio") for $375.0 million in cash.

"Acquiring the full U.S. rights to the Nucynta Franchise is financially transformative for Collegium," said Joe Ciaffoni, President and Chief Executive Officer of Collegium. "We expect the acquisition to improve annual EBITDA and operating cash flows by more than $100 million. The transaction is supported by a financing structure that allows for rapid de-leveraging and enables us to pursue future business development transactions."

Mallinckrodt plc (NYSE: MNK)  a global biopharmaceutical company, recently confirmed enrollment of the first patient in the company's Phase 4, multi-center, multiple-dose, open-label study to assess the effects of Acthar Gel as a therapy option in patients with severe keratitis.

"In my experience, a considerable number of severe keratitis patients can have persistent disease that may not be resolved by first-line treatment," said Eugene McLaurin, MD and Fellow, American Academy of Ophthalmology and American College of Surgeons. "I am pleased that the first patient has been enrolled in this important Phase 4 study, the results of which may potentially provide data to further support Acthar Gel as a treatment option in appropriate keratitis patients."

Endo International plc (NASDAQ: ENDP) recently announced that one of its operating companies, Par Pharmaceutical (Par), has begun shipping an authorized generic version of Allergan's Carafate® (sucralfate) oral suspension 1gm/10 mL.

"Par is proud to partner with Allergan to bring the authorized generic of Carafate® to patients," said Domenic Ciarico, Executive Vice President & Chief Commercial Officer, Sterile & Generics at Endo. "We are pleased to add this product to our portfolio and continue Par's tradition of being a reliable, quality supplier."

Teva Pharmaceutical Industries Limited (NYSE: TEVA) recently announced positive results from two Phase 2/3 trials evaluating AJOVY® (fremanezumab) in patients in Japan. AJOVY is under development in Japan by Otsuka Pharmaceutical Co., Ltd. (Otsuka) as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan.

"This study adds to the wealth of positive AJOVY data we have in patients globally," said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva. "The annual prevalence of migraine in Japan is 8.4% of adults,1 so we are pleased to be one step closer to bringing AJOVY to patients in Japan who could benefit from a preventive treatment."

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