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Update in Drug Development News

June 30, 2017
Microgabalin shows efficacy in Phase 3 trials, TRPV1 gets green light from FDA to begin Phase 1b testing, Cara's CR845 (kappa opioid receptor) misses mark.

Microgabalin for Postherpetic Neuralgia

In a Phase 3 clinical trials of patients with postherpectic neuroalgia treated with microgablin met primary efficacy endpoint. In the study NEURCOURSE, the efficacy of migogabalin in Asian patients with PHN receiving 10 mg and 15 mg twice a day demonstrated significant reduction in daily pain score from baseline at week 14. Mirogabalin is an oral therapy that preferentially and selectively binds to the α2δ-1 (alpha-2 delta-1) subunit on calcium channels widely found in the nervous system in areas that mediate pain transmission and processing. Mirogabalin has a unique binding profile and long duration of action.1

TRPV1 for Cancer-Related Pain

Sorrento Therapeutics has received authorization to launch its New Drug Application for their TRPV1 agonist, RTX.2 The agent selectively targets afferent nerve activation and will be studied in Phase 1b clinical trials for the treatment of intractable cancer-related pain.

RTX has been extensively tested in animals and is currently in Phase 1 trials at the National Institutes of Health. To date 12 patients with terminal cancer pain have been treated with intrathecal injections. During that trials, RTX has been shown to directly interact with nerve cells experssing TRPV1 receptors without affecting normal sensation or muscle function. Results showed that a single injection of RTX was well woterated at the dose levels tested and provided clinically meaningful reduction in pain, noted the company.

Kappa Opioid Misses End Point

A phase 2b trial of Cara Therapeutics' CR845 has missed its primary endpoint.3 An oral formulation of the kappa opioid receptor agonist failed to outperform placebo on a pain score.

Investigators enrolled 476 people with osteoarthritis of the hip or knee in the trial and randomized them to receive 1 of 3 doses of CR845 or placebo. Participants took the tablets twice a day for 8 weeks. Cara gauged the effectiveness of CR845 by tracking subjects' pain intensity scores and comparing them with a baseline.

CR845 failed to move the meeet this primary endpoint. Patients who took the highest dose of CR845 experienced a 35% reduction in mean joint pain score as compared with placebo. This fell short of statistical significance (P = 0.111).

The IV formulation of CR845 is in a phase 3 trial as a treatment for postoperative pain, the continuation of which was supported by an independent committee after an interim review. Cara is also developing the IV formulation as a treatment for pruritus in patients with chronic kidney disease who are undergoing hemodialysis. That is the indication in which the drug now has breakthrough status.

"The drug was observed to be well tolerated over the treatment period and this overall data set will inform both our dose selection and patient population in designing our next trial of oral CR845 in OA patients," Cara CMO Joseph Stauffer said in a statement.3



Last updated on: November 5, 2020
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