Taiwanese pharmaceutical company Xgene Pharmaceutical announced that its non-opioid analgesic drug XG005 has reduced acute pain in patients after surgery in a Phase IIb study[MV1] .
The placebo-controlled, dose-ranging trial (NCT06017999) considered the primary efficacy endpoint of measuring pain through the summed pain index (SPI) over 48 hours after bunionectomy surgery. The study tested two doses of the drug, 1,250 mg and 750mg, and compared them to placebo.
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The pain intensity score was statistically lower for both doses compared to placebo over 72 hours post-surgery. In the high-dose arm, the maximum pain was mild, indicated by less than 4.0 points on the numeric rating scale (NRS). In contrast, the maximum pain was reported to be severe (> 7.0 NRS) in the placebo arm during the same period.
The results demonstrated a statistically significant difference in the provision of analgesia; Xgene reported that 42% of patients in a high-dose group did not use any rescue medication, compared to 33% of patients needing rescue pain drugs in a low-dose group.
Across patients who took XG005 and required rescue analgesics, there was an eight-fold increase in the time to first use. Xgene reported that median times to first use of rescue medication for the high-dose, low-dose and placebo groups were 31.47, 12.24, and 4.03 hours, respectively.
Researchers also observed a four-fold reduction in the total amount of opiate consumption medication required in a 1,250 mg group. A Morphine Equivalent Dose (MEQ) of 6.72mg was needed in the high-dose XG005 group compared to 23.86 mg in the placebo arm, per a daily dose of 24.68mg.
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By GlobalDataXgene also reported that Patient Global Assessment of pain control was statistically better in XG005 treatment arms than in the placebo group across the three-day period, whilst patients’ sleep post surgery was significantly improved in the XG005-treated arms as assessed with Sleep Interference Score.
“Mean pain severity was mild at the most in [the] high-dose group versus severe in placebo group. The amount of rescue medication used, including opioids, was less than 1/3 in the high-dose arm compared with placebo,” said Xgene’s chief medical officer Leon Jiang.
Xgene’s XG005 is a non-opioid analgesic, targeting both nociceptive and neuropathic pain signals. The latest results for the treatment of acute pain (defined as lasting less than 3 months), follow positive Phase IIb trial results of XG005 treatment in chronic osteoarthritis pain in August. The drug is also being tested in a Phase II trial for the treatment of cancer-induced bone pain.
Jiang added: “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.” The need for nonopioid treatments sits against the backdrop of a globally growing issue of opioid addiction. GlobalData reported that, across the eight major pharmaceutical markets (the US, Canada, France, Germany, Italy, Spain, the UK, and Australia), the opioid addiction treatment market was valued at $2bn in 2023; it forecast that the market will grow at a CAGR of more than 1% from 2023 to 2033.
GlobalData is the parent company of Clinical Trials Arena.
