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.
Are you sure you want to Unfollow this Author?
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Family Medicine

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

Most Popular Family Medicine Articles

1 A comparison of different oral therapies versus no treatment for erectile dysfunction in 196 radical nerve-sparing radical prostatectomy patients International Journal of Impotence Research: The Journal of Sexual Medicine, August 12, 2014    Clinical Article

2 Midlife dietary vitamin D intake and subsequent performance in different cognitive domains Annals of Nutrition and Metabolism, September 16, 2014    Clinical Article

3 Aromatherapy for stress reduction in healthy adults: A systematic review and meta-analysis of randomized clinical trials Maturitas, September 3, 2014    Evidence Based Medicine

4 Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: A randomized, double-blind, placebo-controlled, stratified, parallel-group trial Journal of Child Psychology and Psychiatry, September 8, 2014    Clinical Article

5 High risk of failing eradication of Helicobacter pylori in patients with diabetes: A meta-analysis Diabetes Research and Clinical Practice, August 18, 2014    Review Article

6 Proportion of tadalafil-treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia - integrated data from 1499 study participants BJU International, September 12, 2014    Clinical Article

7 Single animal to human transmission event responsible for 2014 Ebola outbreak Full Text NIH News, September 2, 2014    Free full text

8 National trends in the management of low- and intermediate-risk prostate cancer in the United States The Journal of Urology, August 13, 2014    Clinical Article

9 Plasma tocopherols and risk of prostate cancer in the selenium and vitamin E cancer prevention trial (SELECT) Cancer Prevention Research, August 25, 2014    Clinical Article

10 The effect of bupropion XL and escitalopram on memory and functional outcomes in adults with major depressive disorder: Results from a randomized controlled trial Psychiatry Research, August 4, 2014    Clinical Article

11 Neuroendocrine prostate cancer (NEPC) progressing from conventional prostatic adenocarcinoma: Factors associated with time to development of NEPC and survival from NEPC diagnosis-a systematic review and pooled analysis Journal of Clinical Oncology, September 22, 2014    Evidence Based Medicine    Review Article

12 Rapid and durable protection against Ebola virus with new vaccine regimens Full Text National Institute of Allergy and Infectious Disease - News, September 9, 2014    Free full text

13 Comparison of brain structural variables, neuropsychological factors, and treatment outcome in early-onset versus late-onset late-life depression The American Journal of Geriatric Psychiatry, September 18, 2014    Clinical Article

14 Adjunctive triple chronotherapy (combined total sleep deprivation, sleep phase advance, and bright light therapy) rapidly improves mood and suicidality in suicidal depressed inpatients: An open label pilot study Journal of Psychiatric Research, September 19, 2014    Clinical Article

15 Urinating standing versus sitting: Position is of influence in men with prostate enlargement. A systematic review and meta-analysis PLOS ONE, August 1, 2014    Evidence Based Medicine    Review Article
Exclusive Author Commentary

16 Effects of alcohol consumption on cognition and regional brain volumes among older adults American Journal of Alzheimer's Disease and Other Dementias, September 18, 2014    Clinical Article

17 Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96–02/AUO AP 09/95 Trial Full Text European Urology, July 18, 2014    Free full text    Clinical Article

18 The use of metformin in patients with prostate cancer and the risk of death Cancer Epidemiology, Biomarkers & Prevention, September 22, 2014    Clinical Article

19 Metformin in chemotherapy-naive castration-resistant prostate cancer: A multicenter phase 2 trial (SAKK 08/09) Full Text European Urology, August 15, 2014    Free full text    Clinical Article

20 Curcumin for the treatment of major depression: A randomised, double-blind, placebo controlled study Journal of Affective Disorders, July 16, 2014    Clinical Article

Indexed Journals in Family Medicine: American Family Physician, Archives of Family Med, Annals of Family Medmore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close