Post-Surgical Pain Treatment Gains FDA Breakthrough Therapy Designation
ATX101 from Allay Therapeutics is designed for use following total knee arthroplasty in adults and has shown positive results in multiple studies.
The FDA has granted Breakthrough Therapy Designation to ATX101 for the treatment of postsurgical pain following total knee arthroplasty in adults, Allay Therapeutics announced in a release.1 The designation was given to the therapy based on positive data from a recently completed phase 2B exploratory dose-ranging trial, which was concluded early based on efficacy.
Post-Surgical Pain Treatment Gains FDA Breakthrough Therapy Designation / Tada Images - stock.adobe.com
ATX101 is a novel investigational configuration of bupivacaine and a biopolymer that has been designed to provide pain relief after orthopedic surgery. The therapy, which has a high density of medication within a small footprint, is placed in at the end of standard surgery to deliver an analgesic effect over weeks before dissolving into water and carbon dioxide. Allay said ATX101 aims to replace the existing mix of analgesic products used for shorter-term pain management.
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“We’re delighted that the FDA granted Breakthrough Therapy designation for ATX101, which we believe recognizes the clear unmet need for novel non-opioid therapies that may provide extended pain relief to patients in the weeks following TKA surgeries,” Sharon Hall, senior vice president of regulatory affairs at Allay, said in a release.1 “Despite decades of development efforts, current treatment methods provide only a few days of pain relief with complicated treatment regimens.”
The phase 2B study of ATX101 was conducted at 13 sites across the United Kingdom, Australia, and Canada. It included 112 patients who received either 1,000 mg or 1500 mg of the therapy, saline placebo, or bupivacaine. All of the patients also received around-the-clock celecoxib and acetaminophen to simulate a real-world multimodal analgesic protocol. Those who received bupivacaine were given a single administration via local infiltration or adductor canal block.
The study showed that ATX101 had a rapid onset of action and efficacy over the first 24 hours that was comparable to bupivacaine.2 There was a clinically meaningful separation in dose response between the 1500 mg ATX101 group compared to the bupivacaine group through weeks 1, 2 and 3. Patients receiving ATX101 also showed meaningful improvements in key indicators of function through 30 and 60 days.
Additionally, compared to patients who received bupivacaine, those who received ATX101 had a reduction in opioid consumption from day 2 onward. More patients who received ATX101 were opioid-free at earlier time points. ATX101 was generally well tolerated with a comparable safety profile to bupivacaine. The majority of adverse events were mild or moderate.
The positive phase 2B data followed additional data from a phase 1B/2A trial that was concluded early due to efficacy in 2021. Allay said it has planned a phase 2B registrational trial that is expected to enroll 200 participants at US sites early next year.
“ATX101 is designed to provide patients weeks of pain relief enabling an active recovery with less opioids used and less opioid-related side effects and risks,” Hall said in a release.1 “This Breakthrough Therapy Designation will allow us to work closely with the FDA to efficiently advance the ATX101 development program through its clinical and regulatory milestones, and eventual New Drug Application filing.”
READ MORE: Nonopioid Pain Management
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