Twelve-month tolerability and efficacy study of np101, the sumatriptan iontophoretic transdermal system
Headache: The Journal of Head and Face Pain,  Clinical Article

Smith TR et al. – NP101, a transdermal sumatriptan formulation in development for the acute treatment of migraine, demonstrated tolerability and efficacy with successive uses over 12 months in this clinical trial.

Methods
  • Patients diagnosed with migraine who had participated in a randomized, double–blind, Phase III study of the NP101 patch were given the option to use NP101 to treat migraine episodes with moderate or severe headache pain for up to 12 months in this open–label trial.

Results
  • 183 patients applied 2089 study patches.
  • The most common adverse events involved the patch application site (45% of patients).
  • The only non–application–site adverse events reported in >2% of patients were nausea (n = 6, 3.3%), upper respiratory tract infection (n = 6, 3.3%), and nasopharyngitis (n = 4, 2.2%).
  • The incidence of triptan–associated adverse events was 1.6%.
  • Across all visits for investigator assessments, the majority of patients (ranging from 74.7% at Month 1 to 92.2% at Month 9) were scored as having no erythema at patch application sites.
  • For patient assessments, the percentage of patch placement sites scored as having no or minimal redness was 38.2% at the time of patch removal and 65.4% 24 hours after patch activation.
  • Two hours after patch activation across all patch treatments over the 12–month study, 23.8% of initial acute migraine episodes were scored as being free from headache pain, 58.2% as having headache pain relief,78.9% as nausea free, 60.1% as phonophobia free, 53.4% as photophobia free, and 20.7% as migraine free.
  • No evidence of waning tolerability or efficacy was observed over the 12–month study period.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Pain Management

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Pain Management Articles

1 Transforaminal versus parasagittal interlaminar epidural steroid injection in low back pain with radicular pain: a randomized, double-blind, active-control trial Full Text Pain Physician, July 23, 2014    Free full text

2 Radiofrequency ablation for chronic low back pain: A systematic review of randomized controlled trials Pain Research and Management, October 6, 2014    Review Article    Clinical Article

3 Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain The Clinical Journal of Pain, September 23, 2014    Clinical Article

4 Efficacy of dry needling for treatment of myofascial pain syndrome Journal of Back and Musculoskeletal Rehabilitation, October 22, 2014    Review Article    Clinical Article

5 Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999-2010 JAMA Internal Medicine, October 2, 2014    Clinical Article

6 Human umbilical cord mesenchymal stem cell transplantation for the treatment of chronic discogenic low back pain Full Text Pain Physician, July 23, 2014    Free full text

7 Treatment of common low back pain: A new approach to an old problem Pain Practice, June 25, 2014    Clinical Article

8 Disc extrusions and bulges in nonspecific low back pain and sciatica: Exploratory randomised controlled trial comparing yoga therapy and normal medical treatment Journal of Back and Musculoskeletal Rehabilitation, October 1, 2014    Evidence Based Medicine

9 Efficacy of the McKenzie method in patients with chronic nonspecific low back pain: A protocol of randomized placebo-controlled trial Physical Therapy, October 8, 2014    Clinical Article

10 Spinal cord stimulation for the treatment of chronic back pain patients: 500-Hz vs. 1000-Hz burst stimulation Neuromodulation: Technology at the Neural Interface, October 28, 2014    Clinical Article

11 Morphine or oxycodone for cancer-related pain? A randomized, open-label, controlled trial Journal of Pain and Symptom Management, October 29, 2014    Clinical Article

12 Effect of vitamin D on musculoskeletal pain and headache: A randomized, double-blind, placebo-controlled trial among adult ethnic minorities in Norway Pain, September 26, 2014    Clinical Article

13 Efficacy and safety of pregabalin for treating painful diabetic peripheral neuropathy: a meta-analysis Acta Anaesthesiologica Scandinavica, October 24, 2014    Review Article    Clinical Article
Exclusive Author Commentary

14 Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: A systematic review and meta-analysis of randomized controlled trials Journal of Spinal Disorders & Techniques, June 30, 2014    Evidence Based Medicine    Review Article    Clinical Article

15 Sugammadex reduces postoperative pain after laparoscopic bariatric surgery: A randomized trial Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, October 7, 2014    Clinical Article

16 Efficacy of memantine in the treatment of fibromyalgia: a double-blind randomised controlled trial with 6-month follow-up Pain, September 16, 2014    Clinical Article

17 Conservative treatments for lumbar radicular pain Current Pain and Headache Reports, September 19, 2014    Review Article

18 Intradiskal methylene blue treatment for diskogenic low back pain PM&R, August 6, 2014    Clinical Article

19 Benzodiazepine use among chronic pain patients prescribed opioids: associations with pain, physical and mental health, and health service utilization Pain Medicine, October 13, 2014    Clinical Article

20 Opioids versus physical therapy for management of chronic back pain Full Text The Journal for Nurse Practitioners , September 26, 2014    Free full text    Clinical Article

Indexed Journals in Pain Management: more