Non-Opioid Analgesic Shown to Reduce Post-Surgical Pain in Phase 2 Trial
XG005 from Xgene Pharmaceutical is a novel, non-opioid chemical entity that targets anti-nociceptive and anti-neuropathic pain pathways.
Positive results have been announced from a phase 2b trial evaluating the safety, efficacy and pharmacokinetics of XG005 oral tablets for acute pain in patients undergoing bunionectomy, according to a release from Xgene Pharmaceutical.1 The study was conducted in collaboration with Evolution Research Group and Lotus Clinical Research.
Non-Opioid Analgesic Shown to Reduce Post-Surgical Pain in Phase 2 Trial / Pitchayaarch - stock.adobe.com
Results from the trial (NCT06017999) showed that treatment with XG005 resulted in statistically significant and clinically meaningful reduction in post-surgical pain following bunionectomy. The therapy also eliminated the need to use any rescue pain medication in 42% of patients in a high dose group and in 33% of patients in a low dose group.
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XG005 is a novel, non-opioid chemical entity that targets anti-nociceptive and anti-neuropathic pain pathways. The oral therapy, which is a potential first-in-class, is in development to treat both acute and chronic pain. The treatment could provide greater inhibition of pain signal transmission due to its dual mechanism of action, delivering greater pain relief to patients with a positive safety profile.
“There is a substantial need for more efficacious, safer, non-opioid treatment for acute pain, as many patients are unable to get sufficient relief with currently available medicines due to intolerable side effects,” Gene Hsu, CEO of Xgene, said in a release.1 “We are pleased that the results from this trial showed the excellent therapeutic effect of XG005, with the potential to be a better treatment option compared to current therapies.”
The trial was a multi-center, randomized, double-blind, parallel-group, placebo-controlled phase 2b study evaluating the safety, efficacy and pharmacokinetics of XG005 oral tablets compared to placebo for acute pain in patients undergoing bunionectomy. The primary study outcome was summed pain intensity from end of surgery to 48 hours post-surgery. Secondary study outcomes included total tramadol rescue medication consumption, time to first use of rescue medication from end of surgery, and Patient Global Assessment (PGA) at 48 hours.
The study cohort included 450 patients aged between 18 to 80 years who were scheduled to undergo unilateral first metatarsal bunionectomy. The patients randomly received either 50 mg XG005, 1250 mg XG005, or placebo 2 times a day following surgery. The patients were confined in the clinic from check-in through 72 hours post-surgery to monitor safety.
The study showed there was a statistically significant difference in summed pain intensity over 48 hours after surgery between XG005 and placebo, with patients who received 1250 mg of the therapy having significantly more pain relief. Time to first use of rescue medication was delayed up to 8-fold in the 1250 mg group compared with placebo. Patients who received the therapy also showed statistically greater pain control on the PGA over 72 hours compared to placebo.
Additionally, both total opioid consumption and total acetaminophen use over 72 hours was significantly less in the groups who received XG005 compared to placebo.
“I have not seen any analgesics showing such great efficacy in well-controlled multiple center trials,” Leon Jiang, Chief Medical Officer at Xgene, said in a release.1 “This compelling efficacy of XG005 overwhelmingly distinguishes it from other analgesics and we are extremely encouraged to expedite the development for early delivery to patients.”
READ MORE: Nonopioid Pain Management
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