Mirogabalin Besylate Tablets Approved for Diabetic Peripheral Neuropathic Pain in Adults, Marking a Therapeutic Breakthrough

Jul 06, 2024 18:24 CST Updated 18:24

Daiichi-Sankyo

Pharmaceutical R&D Developer

New Drug Approved, Opening a New Era in the Management and Treatment of "Diabetic Pain"!

2024Year6Month28Day-China,Daiichi Sankyo (China) announced that its independently developed innovative drug, Milnacipran Hydrochloride Tablets (Chinese trade name: Delijing, English trade name: TARLIGE), has been approved by the National Medical Products Administration for the treatment of diabetic peripheral neuropathic pain in adults. The approval of this indication is an important milestone in the field of diabetic peripheral neuropathic pain, breaking the long-standing treatment dilemma for this disease and broadening the new landscape for managing diabetic peripheral neuropathic pain in China.

Refusing the "Sweet" Pain: DPNP Urgently Needs More Effective Treatment

Diabetic Peripheral Neuropathic Pain (Diabetic Peripheral Neuropathic Pain (DPNP) is a common chronic complication in people with diabetes and prediabetes. The most common symptoms are symmetrical peripheral neuropathic pain, mainly affecting the distal limbs, and it can also present as mononeuropathy or brachial plexus and lumbosacral plexus neuralgia.¹, and in the past, due to various reasons, the diagnosis and treatment of DPNP did not receive sufficient attention, resulting in many patients being plagued by pain symptoms for a long time.²。

As one of the severe complications of diabetes,DPNP has gradually become a focal point of attention in the global medical field. However, existing analgesic drugs and treatment options still cannot fully meet clinical and patient needs, with limited drug choices and suboptimal treatment outcomes.Patients Urgently Need More Effective Pain Management Methods。

Based on a novel mechanism, Milogabarbin effectively, durably, and safely improves symptoms in DPNP patients.

Mirogabalin besylate tablets, as a third-generation calcium channel modulator drug, target the calcium channel.α₂δ subunit, associated with calcium ion channel α₂δ subunit has high affinity, but with α₂δ-1 subunit (more related to analgesic effects) dissociates slowly, with α₂The δ-2 subunit (more associated with central adverse reactions) dissociates quickly, allowing for a better balance between efficacy and safety, with stronger and longer-lasting analgesic effects in preclinical studies.³。

This approval is based onDS5565-A-A315 Clinical Study Results: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial in China. This trial included a total of 393 subjects and aimed to evaluate the efficacy and safety of Mirogabalin Besylate in treating patients with DPNP. The study results showed, compared with the placebo group,The 15mg meloxicabalin twice-daily dosing group showed statistically significant improvement in pain scores at week 14 (P=0.0301), with notable enhancements in patients' overall impression of pain, sleep, and quality of life.⁴。

In addition, Milnacipran Benzenesulfonate treats AsiaThe pivotal Phase III clinical study in DPNP patients (DS5565-A-J303) showed that the group receiving 15mg of mirogabalin twice dailyImprovement in Pain ScoreIn the 14thSignificant difference compared to the placebo group (P=0.0027).Subsequently52During the open-label extension period of the study，Of the 214 subjects, 169 completed the 52-week study. The average pain intensity decreased from 42.1mm to 31.1mm compared to before treatment. More notably, a Phase III study in patients with renal impairment over a 14-week treatment period (30 moderate, 5 severe) also demonstrated this effect.Mirogabalin BesilateGood safety and tolerability in patients with renal impairment⁴。

Mr. Yashio Uchida, President of Daiichi Sankyo (China)Said: "Daiichi Sankyo (China) is committed to advancing innovative treatment solutions for the management of diabetic peripheral neuropathic pain.Applications in the field help patients overcome treatment challenges and meet their therapeutic needs.Mirogabalin Besilate Tablets"It is another significant achievement by Daiichi Sankyo after years of dedication in this field. In the future, we will continue to accelerate innovation, build a robust, sustainable, and resilient product pipeline, and collaborate with the government, medical institutions, and other parties to improve the accessibility of innovative drugs, providing high-quality products for patients worldwide."

"Daiichi Sankyo is committed to the research, development, and breakthrough of third-generation calcium channel modulator technology, with the original product..."Mirogabalin Besylate Has Been Launched in Japan5Year, this approval in China will"Break the long-standing treatment dilemma in China where no medication is available for diabetic peripheral neuropathic pain."Mr. Tsunehiko Ogata, General Manager of Daiichi Sankyo (China) Development HeadquartersIntroduction: "In the future, Daiichi Sankyo will continue to rely on its independent research and development capabilities, fully realize the global simultaneous development of new drugs, further accelerate the launch of multiple innovative drugs in China, and bring effective treatments and methods to Chinese patients as quickly as possible."

"To improve the quality of life for DPNP patients, we are committed to providing innovative treatment solutions for DPNP patients."TheMr. Koji Higashiyama, General Manager of Medical Headquarters, Daiichi Sankyo (China)Indicates,"To achieve this goal, in the past few years, we have accelerated innovation, explored cutting-edge technologies, and focused on a series of critical drugs including oncology, cardiovascular, respiratory, and analgesic fields. This time..."Mirogabalin Besylate Tablets"The approval highlights Daiichi Sankyo (China)'s patient-centered philosophy and commitment to patients. We will continue to strive to improve the diagnosis and treatment of painful conditions, bringing innovative treatment options to more patients."

Ms. Li Li, Head of Basic Medical Services at Daiichi Sankyo (China)Stated: "Patients with DPNP have long faced the challenge of limited treatment options,Mirogabalin Besilate TabletsAs a third-generation calcium channel modulator, it has ushered in a new era in the management of diabetic peripheral neuropathic pain."We will continue to promote medical education in the future, enhance the diagnosis and treatment capabilities in disease areas through cooperation with academic/industry associations, benefiting more patients in China."

References：

[1] Special Committee on Pain and Sensory Disorders of the Neurology Physicians Branch of the Chinese Medical Doctor Association. Expert consensus on diagnosis and treatment of diabetic peripheral neuropathic pain [J]. Chinese Journal of Pain Medicine, 2018, 24(8): 561-567.

[2] Editorial Board of Chinese Expert Consensus on Peripheral Neuropathic Pain. Chinese Expert Consensus on Diagnosis and Treatment of Peripheral Neuropathic Pain[J]. Chinese Journal of Pain Medicine, 2020, 26(5): 321-328.

[3] Domon Y, Arakawa N, Inoue T, et al. Binding characteristics and analgesic effects of mirogabalin, a novel ligand for the α2δ subunit of voltage-gated calcium channels[J]. Journal of Pharmacology and Experimental Therapeutics, 2018, 365(3): 573-582.

[4] Instructions for Milnacipran Besylate Tablets

AD-105-2024-000453

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