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Breakthrough in Fibromyalgia
The US Food and Drug Administration (FDA) has approved the first
drug to treat fibromyalgia. Pregabalin (Lyrica) can reduce the
pain associated with fibromyalgia in some patients, and also may
improve daily functions, although the mechanism by which it produces
its effect is unknown. Pfizer Inc’s drug is already approved
for treating partial seizures, pain following the rash of herpes
zoster, and pain associated with diabetic neuropathy. Approval
for the new indication was based on a series of clinical trials
involving approximately 1,800 patients with fibromyalgia. Pfizer
will be performing additional studies of the drug in breastfeeding
women and
in children.
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Improving Assisted Reproductive Technology
Ferring Pharmaceuticals has received FDA approval for
their progesterone, 100 mg, vaginal insert (Endometrin) indicated for supplementation of the corpus luteal function
to facilitate embryo implantation and early pregnancy in infertile female patients. The quick-dissolving tablet has
a disposable polyethylene
applicator and is administered
starting at oocyte retrieval, then two or three times daily for up to 10 weeks. Approval was based on the results from
a multicenter, randomized, open-label, assessor-blinded trial of 1,211 in-vitro fertili-zation patients, in which
continuing pregnancy rates were 40% and 44% for progesterone two and three times daily, respectively.
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A New “Light”
Welch Allyn recently introduced their improved disposable vaginal specula (KleenSpec) and cordless illumination system to the market. The vaginal specula’s new light-emitting diode (LED) system provides enhanced visualization for improved patient care and reduces the amount of heat emitted compared to other lighting systems. While the cordless system is easier to use in the examination room, the new light probe provides homogeneous LED projection of focused white light to eliminate glare.
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Monitoring Under
the Skin
DexCom, Inc’s, 7-day glucose monitoring system (STS-7 Continuous Glucose
Monitoring System) has received FDA approval for the measurement of glucose
levels in diabetes mellitus patients aged 18 years and older. As a supplement
to standard fingerstick tests, the 7-day system measures the amount of glucose
found in the body’s interstitial fluid via a disposable sensor inserted
under the abdominal skin. The sensor wirelessly transmits data to a handheld
receiver that conveniently fits on a belt or in a handbag. Approval followed
the results of five clinical trials involving 72 diabetes mellitus patients,
in which the system proved safe and effective at detecting glucose-level trends
and patterns.
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Reducing Errors
The FDA recently approved
for marketing Inrange Systems, Inc’s, programmable medication dispensing device (Electronic Medication Management
Assistant) designed to reduce drug identification and dosing errors in the outpatient setting. The medication dispenser
is equipped with a two-way communication system that gives health care providers the ability to monitor a patient’s medication regimen. Comprised of a delivery and storage unit, an audible alarm sounds to alert the patient when to take the appropriate dose of medication.
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Combo ARB and CCB
After receiving tentative FDA approval in December 2006, Novartis AG was granted final approval for their combination valsartan (Diovan) and amlodipine (Norvasc) tablets (Exforge) indicated for the treatment of high blood pressure in patients not responsive to other blood pressure medications. The combination angiotensin receptor blocker and calcium channel blocker prevents blood vessel constriction caused by angiotensin II activity and eases blood flow by blocking the entrance of calcium into the blood vessels. Approval followed two placebo-controlled clinical trials in which 90% of participants reached their diastolic blood pressure goal of less than 90 mm Hg, or experienced a minimum of a
10 mm Hg rate of reduction.
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Seeing a Little Clearer
Advanced Medical Optics, Inc, has received FDA approval
for a new laser-assisted in-situ keratomileusis procedure (Advanced CustomVue Monovision). It is the first FDA-approved wavefront-guided laser correction procedure for the treatment of myopic, presbyopic patients with or without astigmatism. As part of the approval agreement, the company will conduct a post-marketing surveillance study because of its first-in-class technology.
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“Patching” Dementia
Initially approved in capsule
form to treat Alzheimer-related dementia in 2000 and Parkinson-related dementia in 2006,
Novartis AG’s rivastigmine (Exelon) is FDA-approved as a new transdermal system. The cholinesterase inhibitor transdermal patch provides a steady dose of the drug over a 24-hour period, and data shows it causes three times fewer side effects, such as nausea and vomiting, than the original capsule form.
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