- Heron reports positive data from its knee replacement trial.
- Adamas Gocovri sNDA accepted.
- Insulet resumes pivotal insulin trial.
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Heron Reports Positive Results From Mid-Stage Knee Replacement Trial
Heron Therapeutics (NASDAQ:HRTX) announced that its Phase 2b clinical trial Study 209 has provided positive data with regard to HTX-011. The trial involved testing the drug candidate on patients undergoing total knee arthroplasty. The company stated that the HTX-011 met all primary and secondary endpoints of the study. The drug candidate also showed good tolerance and comparable safety profile.
Study 209 is a Phase 2b study and aimed to assess the potential of HTX-011 in primary unilateral total knee arthroplasty. The patients were given a single, needle-free administration of the drug candidate. The subjects showed a superior pain reduction when compared to patients given placebo or bupivacaine solution through 48 and 72 hours. The patients also consume fewer opioids in comparison to control arm. Fewer patients on the drug candidate reported severe pain through 72 hours. Also, more patients on HTX-011 were assessed ready for discharge at 8, 12, and 24 hours, in comparison to patients receiving bupivacaine solution or placebo.
HTX-011 was found to be well-tolerated in Study 209, and its safety profile was comparable to bupivacaine solution and placebo. Alan J. Rechter, M.D., an orthopedic surgeon at Orthopaedic Associates, LLP said,
"Effective pain management is crucial after TKA to permit earlier mobilization, maximize patient satisfaction and facilitate outpatient surgery. Based on my experience in Study 209, the fast and easy needle-free administration of HTX-011 provided patients with effective and improved pain control despite taking fewer opioids."
Study 209 was a randomized, placebo- and active-controlled, double-blind to assess the analgesic efficacy, safety and pharmacokinetics of the drug candidate locally administered into the surgical site. After the dose escalation phase, 232 patients were randomized. 222 patients were given different combinations of (1) HTX-011 400 mg bupivacaine/12 mg meloxicam given through instillation into the surgical site; (2) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via instillation into the surgical site plus a low dose of ropivacaine solution injected into the posterior capsule; (3) bupivacaine solution 125 mg administered via multiple injections into the surgical site; or (4) placebo. The study included a pre-specified hierarchical testing strategy for the primary and key secondary endpoints for the HTX-011 400 mg bupivacaine/12 mg meloxicam treatment groups.
The primary endpoint of the study was pain intensity in comparison to placebo. The pain intensity was to be measured by the Area Under the Curve from 0 to 48 hours post-surgery. The drug candidate on its own and in combination with ropivacaine solution showed improvement of 19% and 22%, respectively, in pain intensity through 48 hours. The pain intensity data through 72 hours showed 18% and 22% improvement, respectively.
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. This investigational non-opioid is the first and only extended-release local anesthetic to show significant reduction in pain and opioid use through 72 hours in Phase 3 studies. The FDA has conferred Fast Track designation and Breakthrough Therapy designation to HTX-011. The expected PDUFA date for the drug is June 26, 2020. Its Marketing Authorization Application has been validated by the European Medicines Agency in March 2019.
Adamas Announces FDA Acceptance of Gocovri Application
Adamas Pharmaceuticals (ADMS) announced that the FDA has accepted its supplemental marketing application for the expanded use of Gocovri. The FDA has set February 1, 2021, as its action date. The application requests the approval for the drug to be used for treating OFF episodes in Parkinson's disease patients on levodopa-based therapy.
The sNDA contains a proposed revision to the indication statement to include that the drug is an appropriate therapy for treating OFF episodes in certain PD patients. The data supporting the application belongs to two large pivotal Phase 3 trials. Neil F. McFarlane, Chief Executive Officer said,
"We are pleased the FDA has accepted our sNDA for review. If approved, the indication would reflect the full spectrum of GOCOVRI's therapeutic benefit in PD motor complications and better support physicians to identify appropriate treatments for their patients."
Gocovri is the first and only FDA-approved medicine indicated for treating dyskinesia in certain patients suffering from Parkinson's disease.
Gocovri is designed to be taken once a day at bedtime. It offers an initial lag and subsequent slow increase in amantadine concentration during the night. As per the data provided by clinical trials, no dose change is required to be made to dopaminergic therapies while using Gocovri. The most commonly occurring adverse reactions associated with the use of the drug were dry mouth, hallucinations, peripheral edema and constipation.
Gocovri was approved by the FDA in 2017 for treating dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, becoming the first medicine approved for the indication. Dyskinesia is caused by levodopa-based Parkinson's disease treatment and results in erratic involuntary movements.
Insulet Resumes Pivotal Insulin Study
Insulet (PODD) announced that it has resumed its pivotal study pertaining Omnipod, a smartphone-controlled automated insulin delivery system. The study was paused in March and involved 240 patients. The study pause was caused by a software anomaly. The company has also changed its US launch target to the first half of 2021. The system is powered by Horizon.
The Insulet study was originally started in 2019 and was scheduled to be completed in July 2020. The study had already completed 9,000 patient days on the system out of the proposed 21,000 patient days as on the time of pause. Dr. Trang Ly MBBS FRACP PhD, Senior Vice President, Medical Director said,
"We are thrilled to continue our trial. We have encouraging data from our clinical work to date and overwhelmingly positive feedback from participants and investigators. We are excited about what our next-generation Omnipod, Powered by Horizon, will offer people living with diabetes."
Insulet focuses on developing therapies for diabetes and other conditions, using its Omnipod product platform. This system provides alternatives to traditional insulin delivery methods. The system is wearable and has a simple design. This disposable pod is designed to administer up to three days of non-stop insulin without using a needle.
The software anomaly, causing the pause, involved the administration of an incorrect amount of insulin. The study was paused to update the software to fix the problem. The company's Horizon technology, which is being used in the trial, was given breakthrough device status in 2018. Insulet also plans to use its pod for delivering non-insulin subcutaneous drugs across various other therapeutic areas.
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