CYPRESS BIOSCIENCE DEBUTS PAIN MONITORING SYSTEM.
The report described studies conducted in collaboration with Dr. Daniel Clauw at the Department of Rheumatology, Georgetown University.
This presentation summarized the results of a pilot study evaluating the use of a Patient Electronic Diary (PED) as a method of assessing chronic pain in patients with fibromyalgia syndrome (FMS). Assessing the level of a subjective symptom, such as pain, over a period of time has long been recognized as a difficult problem in clinical research. Because there is no objective means to measure pain, assessment necessarily involves asking the subject to rate their level of pain, either in real-time or recalled over some interval. However, relying on a subject's recall of a subjective symptom such as pain is prone to bias. In particular, it has been documented that the recall of pain is significantly biased by the level of pain at the time the subject is asked. Such bias can impact the outcome of clinical trials of novel analgesics, since an improvement in symptoms may be overlooked because of a measurement taken a time of temporary exacerbation of symptoms.
Cypress worked with invivodata inc.(TM) to develop the PED to collect patient-reported real-time data to improve the quality of the information. The electronic diary system allows one to collect patient-reported real-time data, as opposed to relying on a traditional paper diary system wherein a patient has to recall and record in a journal pain experienced at some prior time.
This 3-month, non-interventional pilot study enrolled 14 patients from the Georgetown University Pain and Chronic Fatigue Center. Each subject carried a PED, and at 4-6 random times per day they were prompted to rate their current level of pain. They were also prompted to complete reports each morning and evening providing additional clinical information. The results from the PED were compared with results obtained by implementing a paper and pencil version of the same pain scale in the clinic setting.
The analyses of the pilot data showed that the real-time data more accurately reflected patients' experiences than weekly or monthly summaries of their pain. The real-time sampling method using the PED allowed for a much more detailed profile of the patient's pain experience over the 3 month period. The ability to collect pain and fatigue data in near real-time, and the ability to collect far greater amounts of information, provides a dataset that is less dependent on spurious events that impact the patient both in the clinic setting and during the trial period.
"Cypress is adding a level of analytic rigor to the assessment of pain in FMS patients. By doing so the company is making a significant contribution to the field as a whole and is positioned to set the standard for characterizing pain in a wide variety of pain syndromes," said Randall Carpenter, M.D., chief executive officer of Sention, and a noted expert in the study of pain.
Cypress' experience with the invivodata(TM) system in this pilot trial convinced the company to use it in the current Phase II trial of the drug Milnacipran, an NSRI (norepinephrine and serotonin reuptake inhibitor), which is being evaluated as a potential treatment for FMS.
About Cypress Bioscience Inc.
Cypress is committed to be the innovator and commercial leader in providing products for the diagnosis and treatment of patients with Functional Somatic Syndromes, such as Fibromyalgia Syndrome, or FMS, and other related chronic pain and central nervous system disorders. In January 2001, the company began a strategic initiative focusing on FMS. In August 2001, Cypress licensed its first product for clinical development, Milnacipran. Milnacipran, the first of a new class of agents known as NSRI's, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while appearing to lack the side effects associated with the latter. Milnacipran is currently being evaluated as a potential treatment for FMS in a Phase II clinical trial.
For more information, visit http://www.cypressbio.com and http://www.FMSresource.com or call 858/452-2323.
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|Comment:||CYPRESS BIOSCIENCE DEBUTS PAIN MONITORING SYSTEM.|
|Publication:||Biotech Equipment Update|
|Article Type:||Brief Article|
|Date:||Oct 1, 2002|
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