Lotus Clinical Research  has a clinical trial testing its non-opioid pain medication called CA-008 during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy), also known as bunion surgery.

Multiple Studies at Lotus Clinical Research

According to what the sponsor published on Clincialtrials.gov the study ran from March 2019 to August, 2019 and involved 36 participants. Sponsored by Concentric Analgesics, the study’s results are important to determine the efficacy of this non-opioid medication. Another bunion surgery study completed at the end of 2018 and included Lotus Clinical Research, HD Research (Houston) and Chesapeake Research Group.

Investigational site Lotus Clinical Research concluded another study during July of this year.  A Phase II, single center, randomized, double-blind, placebo-controlled, parallel design study, sponsor Concentric Analgesics sought to test again CA-008 versus a placebo in patents undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCI)  transverse abdominis place (TAP) block. Alina Beaton, MD served as Principal Investigator for this study.

HD Research in Houston Studies CA-008 for Knew Replacement

In Houston, HD Research partnered with Concentric Analgesics to complete a Phase II study of CA-008 versus placebo injected/instilled during a Total Knee Arthroplasty (knee replacement). Targeting acute post-surgical pain, this study included 54 participants and was completed during the summer of 2019 as well.

Can Non-Opioid Pain Medication Work: What is CA-008?

CA-008 is a first-in-class non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist. The investigational treatment recently was assigned Breakthrough Therapy status by the Food and Drug Administration (FDA) for post-surgical pain. In 2017, it received “Fast-Track” designation by the FDA.

CA-008 provides long-lasting pain relief after a single, local injection by selectively desensitizing pain-conducting nerve fibers, without producing numbness or weakness. CA-008 is currently in Phase II of its clinical development.

Who is Concentric Analgesics? 

A clinical-stage biopharmaceutical company, they focus on developing and commercializing novel, non-opioid pain therapeutics. The company’s portfolio of proprietary TRPV1-agonist prodrugs is designed for long-lasting, selective pain relief after a single local injection. They have three active programs for multiple indications with significant unmet need including 1) post-surgical pain 2) osteoarthritis and 3) chronic refractory pain. Their pipeline evidences clinical stages for each.

The venture was founded by anesthesiologist John Donovan, MD, MBA, and chemist Craig Husfeld, PhD


According to CrunchBase, the venture, launched in 2014, has raised over $80 million by Series B round of funding.

An Alternative to Opioids for Post-Surgical Pain

This is a big deal. Opioid addiction in the United States has reached epidemic proportions—destroying families and communities in the process. The Centers for Disease Control reports that 70,000 Americans died from opioid overdoses in 2017. Less addictive alternatives are greatly needed.

Call to Action: Interested in learning more about this investigational non-opioid pain medication? We recommend monitoring the commercial sponsor but also learn more from the clinical investigational sites, such as Lotus Clinical Research, or VeevaHD Research in Houston and Chesapeake Research Group

Source: ClinicalTrials.gov

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