Mark Pierce

Zelrix™: A Novel Transdermal Formulation of Sumatriptan

Objective.— This study evaluated the pharmacokinetic and tolerability profiles of Zelrix™ (NuPathe Inc., Conshohocken, PA, USA), the novel formulation of sumatriptan (formerly known as NP101).

A Sumatriptan Iontophoretic Transdermal System for the Acute Treatment of Migraine

Objective.— Gastrointestinal symptoms, such as nausea and vomiting, occur almost universally at one time or another in patients during a migraine attack. One third of patients who experience migraine‐related nausea report that this symptom interferes with their ability to take oral medications. The sumatriptan iontophoretic transdermal system (NuPathe Inc., Conshohocken, PA, USA) uses proprietary technology to circumvent the gastrointestinal tract while delivering triptan therapy. This phase III randomized, double‐blind, placebo‐controlled trial evaluated the efficacy and tolerability of this system for the acute treatment of migraine.

Twelve-Month Tolerability and Efficacy Study of NP101, the Sumatriptan Iontophoretic Transdermal System

Objective.— To assess the long‐term tolerability and efficacy of NP101, a novel transdermal sumatriptan patch being developed for the acute treatment of migraine.

Sumatriptan Iontophoretic Transdermal System: History, Study Results, and Use in Clinical Practice

Nausea is a common symptom of migraine, and current treatment guidelines recommend non‐oral formulations for nauseated or vomiting patients. Transdermal delivery of sumatriptan, a 5‐hydroxytryptamine1B1D agonist with established efficacy in patients with migraine, represents a novel approach to acute treatment. The sumatriptan iontophoretic transdermal system circumvents the gastrointestinal tract by using low‐level electrical energy to transport sumatriptan across the skin. In multiple well‐controlled studies, the sumatriptan transdermal system has shown that it provides consistent drug delivery with low interpatient variability, rapid relief of migraine pain and associated symptoms, and an excellent overall safety profile, with a low incidence of triptan‐sensation adverse events. Patients and health care professionals who have used the sumatriptan transdermal system give it high ratings for ease of use/application. The sumatriptan transdermal system will allow a wide range of patients, especially those who experience migraine‐related nausea or vomiting, to receive the benefits of migraine‐specific therapy.

Sumatriptan Iontophoretic Transdermal System Reduces Treatment-Emergent Nausea and Is Effective in Patients With and Without Nausea at Baseline – Results From a Randomized Controlled Trial

To test the hypothesis that sumatriptan iontophoretic transdermal system (TDS) is associated with lower rates of treatment‐emergent nausea (TEN) relative to placebo, as well as to compare the efficacy of sumatriptan TDS in migraineurs with or without nausea at baseline.

Sumatriptan Transdermal System Can Be Correctly Assembled and Applied During Migraine Attacks

The objective of this study was to validate the ease of assembly and application of the sumatriptan iontophoretic transdermal system (sumatriptan TDS, Zecuity®, NuPathe, Inc., Malvern, PA, USA) during a migraine attack.

Oral triptans and nausea: treatment considerations in migraine.

The objective of this paper is to review evidence showing that migraine patients who are nauseated before using oral triptans tend to have a poor treatment response, as well as to establish a framework for further investigation of the association between response to oral medications and pretreatment nausea among migraineurs.

A Phase I, Open-Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of the Sumatriptan Iontophoretic Transdermal System in Adolescent Migraine Patients.

To evaluate the safety, tolerability, and pharmacokinetics of sumatriptan delivered by the iontophoretic transdermal system (TDS) in adolescent patients.

The efficacy of transdermal sumatriptan is too low for general use - a response.

Headache carries the subtitle, the journal of head and face pain. A chance encounter years ago led to my attendance at a meeting of the American Association for the Study of Headache (AASH), now the American Headache Society (AHS). Dentists were invited to join. The reason was to gain a broader knowledge base that could be applied clinically in dental practice where many patients with symptoms involving the face, and especially the temporomandibular joint, were seen.These patients often complained of muscular and vascular issues that could not logically, nor physiologically, be attributed simply to jaw joint pathology. Their initial complaint was often ipsilateral maxillary sinus region discomfort. Thus began a lifelong search for answers to these patients’ needs. Exposure to the work of Drs. Harry Sicher, Walter Penfield, and others provided foundation, as did Gray’s Anatomy and other texts.The faculty at AASH meetings questioned the validity of some dental presentations and admonished us to go home to settle our dental arguments. Embarrassing? Yes. Yet, the gentle touch of Drs. Seymour Solomon and Keith Campbell provided encouragement of my easily intimidated curiosity and quest for answers, as I wandered, like a lost infantryman, in no man’s land! Neurology is a complicated science . . . like a treasure hunt,even with just one astrocyte to explore . . .but there are trillions!! Good news, the mind is a wonderful thing to boggle! Focus now on the temporomandibular joint symptom complex.My background includes dental education,personally experiencing temporomandibular dysfunction (TMD) syndrome,and a privileged exposure to many patients’ problems, both mental and physical. Continuing education, looking for answers, has been professionally and personally fulfilling. From this collective experience and knowledge, a treatment protocol evolved that is scientifically credible and has been clinically proven to be extremely successful. The anatomic and neurological connections of the teeth must be considered. Now, being able to give patients an understandable rationale for their symptom complex contributes greatly to their healing.This had to involve basically ignoring the very jaw joint symptoms that were causing discomfort and psychological distress for the patient in the first place. The acronyms TMJ (temporomandibular joint dysfunction), CMD (craniomandibular dysfunction),TMD, etc, did not accurately represent the anatomical, physiological, and psychological components of this perplexing symptom/ sign complex. Craniomandibular neurovascular dysfunction syndrome (CMNVD) is more inclusive. The jaw joint symptom site, other signs and symptoms, as well as psychological factors such as the stress of daily living can fit within this syndrome. Dr.Allan Purdy’s definition of a syndrome is “a disease process with emphasis on the word process.”This is perfectly apropos while trying to understand the pathogenesis of CMNVD. A review of patient files, a visit with a statistician, and the expression of collected data as bar graphs led to interesting and startling conclusions. Although a crude clinical study, its revelations supported the thesis that a broader, yet definitive approach should be employed in the treatment of CMNVD (TMD). The implications of associated neurovascular pathology are very important to both medicine and dentistry, especially in regard to headache issues. New, carefully documented studies are now needed to confirm or deny the validity of this work.The importance to medicine, dentistry, and patient welfare is undeniable. Validation will mandate a renewal of cooperation between all health professionals and the recognition of the skill levels required to diagnose, treat, and communicate to patients the generally innocuous nature of CMNVD and its good prognosis. Reducing treatment time from years to weeks is a giant step forward. Any contribution to headache science will be an added benefit. This thesis is submitted as a challenge to all health professionals to review their personal belief systems regarding TMD. More research needs to be done in the field of dental and facial pain.They must be prepared for a major paradigm shift, if it proves to be scientifically grounded. That is their obligation as students, confidants, and purveyors of knowledge to the human family, to whom we have pledged our oath of service.