Albert Einstein College of Medicine, Bronx, NY, USA.
Promius Pharma, A Subsidiary of Dr. Reddy's Laboratories, Princeton, NJ, USA.
CNS Drugs. 2019 Apr;33(4):375-382. doi: 10.1007/s40263-019-00614-6.
The commercial formulation of sumatriptan nasal spray is an effective option for migraine patients requiring or preferring a non-oral route of drug administration, but its utility is limited by poor absorption and tolerability issues. DFN-02, a new formulation of sumatriptan 10 mg nasal spray, is co-formulated with a permeation enhancer that gives it pharmacokinetics comparable to subcutaneous sumatriptan. As reported previously, DFN-02 was significantly better than placebo on multiple efficacy endpoints at 2 h postdose, including pain freedom, absence of the most bothersome symptom, and pain relief, and its safety and tolerability profiles were excellent.
The objective of this study was to assess the efficacy of acute treatment of migraine with DFN-02, including its effect on migraine-related functional disability and patient satisfaction with treatment.
This was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-02 in adults with episodic migraine. Functional disability and subject satisfaction with treatment were prespecified endpoints, assessed in real-time by subjects, using an electronic diary.
In total, 107 subjects were randomized. DFN-02 was significantly superior to placebo for the reduction in functional disability score from predose level at 2 h after treatment (- 1.2 vs. - 0.6, p < 0.001). Subjects treated with DFN-02 were also more likely to be satisfied or very satisfied than subjects treated with placebo at 2 h postdose (70.0% vs. 44.2%, p = 0.027). Using the Patient Perception of Migraine Questionnaire-Revised at 24 h postdose, DFN-02 mean scores were significantly superior to placebo for the subscales of efficacy (65.2 vs. 42.5, p = 0.016) and function (68.9 vs. 42.1, p = 0.001), and for total score (71.0 vs. 56.6, p = 0.016); global medication effectiveness (p = 0.027); and overall satisfaction (p = 0.019). Placebo was significantly better than DFN-02 on the tolerability subscale (94.8 vs. 88.5, p = 0.026). At 24 h postdose, subjects reported significantly higher satisfaction with DFN-02 compared with satisfaction reported pre-randomization regarding their usual migraine medication (p = 0.012).
DFN-02 was superior to placebo for the relief of migraine-related functional disability, and provided greater satisfaction than placebo or subjects' usual acute treatment.
ClinicalTrials.gov identifier: NCT02856802.
舒马曲坦鼻喷雾剂的商业配方是需要或偏好非口服给药途径的偏头痛患者的有效选择，但由于吸收不良和耐受性问题，其应用受到限制。DFN-02 是一种新的舒马曲坦 10mg 鼻喷雾剂配方，与渗透增强剂联合配制，使其药代动力学与皮下舒马曲坦相当。如前所述，DFN-02 在给药后 2 小时的多个疗效终点上明显优于安慰剂，包括疼痛缓解、无最困扰症状和疼痛缓解，且其安全性和耐受性良好。
本研究旨在评估 DFN-02 治疗偏头痛的急性疗效，包括其对偏头痛相关功能障碍和患者对治疗的满意度的影响。
这是一项多中心、随机、双盲、安慰剂对照的 DFN-02 治疗成人发作性偏头痛的疗效和安全性研究。功能障碍和患者对治疗的满意度是预先指定的终点，由患者使用电子日记实时评估。
共有 107 名患者被随机分配。DFN-02 在治疗后 2 小时从预剂量水平降低功能障碍评分方面明显优于安慰剂（-1.2 与-0.6，p<0.001）。与安慰剂组相比，接受 DFN-02 治疗的患者在 2 小时后更有可能感到满意或非常满意（70.0%与 44.2%，p=0.027）。使用偏头痛患者感知问卷修订版（Migraine Patients Perception Questionnaire-Revised）在 24 小时后评估，DFN-02 的评分在疗效（65.2 与 42.5，p=0.016）和功能（68.9 与 42.1，p=0.001）、总评分（71.0 与 56.6，p=0.016）以及全球药物有效性（p=0.027）和整体满意度（p=0.019）方面明显优于安慰剂。在耐受性方面，安慰剂明显优于 DFN-02（94.8 与 88.5，p=0.026）。在 24 小时后评估，与患者对常规偏头痛药物的满意度相比，患者对 DFN-02 的满意度明显更高（p=0.012）。
DFN-02 优于安慰剂，可缓解偏头痛相关的功能障碍，并提供比安慰剂或患者通常的急性治疗更大的满意度。
ClinicalTrials.gov 标识符：NCT02856802。
