| NEW
PRODUCTS
Taclonex Available
by Prescription for Treatment of Psoriasis Vulgaris
Warner Chilcott, Rockaway, NJ, and LEO Pharma, Denmark,
Copenhagen, have announced that Taclonex (calcipotriene
0.005% and betamethasone dipropionate 0.064%), a once-daily
ointment for the treatment of psoriasis vulgaris in adults,
is now available for prescription in the United States.
The product is available outside of the United States as
Dovobet or Daivobet. It was cleared for marketing by the
US Food and Drug Administration in January.
In clinical trials, most patients with
psoriasis saw improvement within the first week of use.
Efficacy and safety of the product were demonstrated in
7 large, multicenter clinical trials that enrolled approximately
7000 psoriasis patients (more than 3000 were treated with
Taclonex) who were agreeable to topical therapy, and who
had lesions affecting at least 10% or one or more body regions.
Patients treated with Taclonex had greater and more rapid
improvement in the Psoriasis Area and Severity Index when
compared with patients treated with either calcipotriene
or betamethasone dipropionate alone, according to the manufacturer.
Information: http://www.warnerchilcott.com;
http://www.leopharma.com
INDUSTRY UPDATES
HEALTHPOINT Set to
Market and Sell Collagenase Santyl
On April 3, 2006, HEALTHPOINT, Fort Worth, TX, began sales
of the Collagenase Santyl ointment product line. The marketing
and selling of the products builds on HEALTHPOINT's
recent purchase of the topical collagenase business from
BioSpecifics Technologies Corporation, Lynbrook, NY.
Collagenase Santyl ointment
is a sterile enzymatic ointment used to debride pressure
ulcers, chronic dermal ulcers, and severely burned areas
by digesting collagen, a major component of devitalized
tissue. The enzyme collagenase is derived from the fermentation
of the bacterium Clostridium histolyticum.
Information:
http://www.healthpoint.com
First
Treatment Guidelines for Diabetic Peripheral Pain Announced
Consensus guidelines for the treatment of diabetic peripheral
neuropathic pain (DPNP), authored by the American Society
of Pain Educators (ASPE), Montclair, NJ, have been published
in the Mayo Clinic Proceedings journal of the Mayo
Clinic College of Medicine, Rochester, MN. For the first
time, these guidelines provide health care professionals
with a definitive and consistent treatment strategy for
the management of pain associated with diabetes. The ASPE
Consensus Guidelines for DPNP were designed to help improve
treatment outcomes and minimize medical errors for the estimated
1 million individuals who have diabetes and debilitation
DPNP.
The guidelines were developed
under an educational grant from Eli Lilly and Company, Indianapolis,
IN, and were jointly sponsored by the Johns Hopkins University
School of Medicine, Baltimore, MD, and the ASPE. They were
published as a continuing medical education supplement in
the April 2006 issue of the Mayo Clinic Proceedings.
Information: http://www.mayoclinicproceedings.com;
http://www.paineducators.org
National
Healing Corporation Receives National JCAHO Certification
National Healing Corporation (NHC), Boca Raton, FL, has
earned the Gold Seal of Approval for health care quality.
The Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) awarded the company a Disease Specific Care Certification
for wound care. The firm accounts for more than 20% of the
nation's managed wound healing centers specializing in the
treatment of chronic and nonresponsive conditions.
The JCAHO certification applies to all
NHC centers that have been open for more than 4 months and
have begun participating in the disease-specific care quality
indicators. NHC's Wound Healing Centers average a
healing rate of 81% on previously nonresponsive wounds and
have reduced amputation rates to 2%.
Information:
http://www.nationalhealing.com
New
CPT and HCPCS J Codes Released by the AMA and CMS
HEALTHPOINT, Fort Worth, TX, announced that as of January
1, 2006, the American Medical Association has released 2
new current procedural terminology (CPT)* codes that are
relevant to the application of OASIS products. In addition,
the Centers for Medicare & Medicaid Services has introduced
a new HCPCS Level II code relevant to OASIS products.
The new code descriptions are
detailed below for easy reference:
| CPT code 15430 |
Acellular
xenograft implant; first 100 sq cm or less, or 1% of
body area of infants and children |
| CPT code 15431 |
Acellular xenograft implant;
each additional 100 sq cm, or each additional 1% of
body area of infants and children, or part thereof (list
separately in addition to code for primary procedure) |
HCPCS Level II
J7341 |
Dermal (substitute) tissue
of nonhuman origin, with or without other bioengineered
or processed elements, with metabolically active elements,
per square centimeter |
The OASIS Wound Matrix is a
bioresorbable, 3-dimensional, cell-free matrix derived from
porcine small intestinal submucosa that is indicated for
the management of partial and full-thickness wounds, such
as venous ulcers and diabetic foot ulcers.
* CPT is copyright 2005, American Medical
Association. All rights reserved.
Information: http://www.healthpoint.com
CLINICAL STUDIES
Bioelectronics Corporation
Partners with Lahey Clinic for ActiPatch Studies
Bioelectronics
Corporation, Frederick, MD, and the Lahey Clinic, Boston,
MA, are launching a 3-year study of ActiPatch on a variety
of soft tissue injuries and related medical conditions.
The Lahey Clinic, whose faculty is affiliated with the medical
schools at Harvard and Tufts, will initiate double-blind
clinical studies on ActiPatch in the areas of plastic surgery,
orthopedics, and chronic wound care.
ActiPatch is a drug-free anti-inflammatory
product with an embedded battery-operated microchip that
delivers weeks of continuous pulsed therapy, according to
the manufacturer. Its patented technology is designed to
provide a cost-effective method to reduce soft tissue pain
and swelling.
Information: http://www.bioelectronicscorp.com
Clinical
Results for Diabetic Neuropathy Drug Trial Presented
Sangamo BioScience, Inc, San Diego, CA, announced positive
results from the Phase I
human clinical trial of SB-509, the company's ZFP Therapeutic
(zinc finger DNA-binding protein transcription factor [ZFP
TF]) for the treatment of diabetic neuropathy. Safety data
and preliminary findings were presented at the 58th Annual
Meeting of the American Academy of Neurology in San Diego
and are the first publicly reported data from a human trial
of a ZFP Therapeutic.
SB-509 is designed to directly protect and
restore nerve function by upregulating the expression of
the gene encoding vascular endothelial growth factor in
patients with diabetes who suffer from peripheral neuropathy.
The study's main objective was to test clinical and
laboratory safety. In the single-blind, single-treatment,
dose-escalation trial, 12 patients with mild to moderate
diabetic peripheral neuropathy received the agent by intramuscular
injection in a distribution along the major peripheral nerves
in the legs and feet. Improvements in pain, numbness, and
neurologic symptoms were observed in about 50% of patients
who received a single treatment of SB-509. Anecdotal improvements
were also reported in neurologic examination scores and
electrophysiologic testing.
Information: http://www.sangamo.com
SkinMedica
Reports Positive Findings for HydroGel Technology
SkinMedica, Inc, Carlsbad,
CA, reported the positive outcome of 2 Phase III clinical
trials evaluating Desonate (desonide) HydroGel 0.05%, a
low-potency topical steroid formulated in a proprietary
alcohol-free, aqueous gel delivery vehicle to treat atopic
dermatitis. The multicenter, randomized, double-blind, placebo-controlled
comparison study involved 582 pediatric patients, ages 3
months to 18 years, with mild to moderate atopic dermatitis.
Patients received either Desonate HydroGel or placebo twice
daily for 4 weeks.
Results demonstrated a significant treatment
effect for Desonate HydroGel in both primary and secondary
endpoints. The product was well tolerated and the most frequently
observed adverse effects were mild in nature and largely
limited to application site reactions. No serious adverse
effects were reported.
Information: http://www.skinmedica.com
Soriatane
Study Shows Effectiveness in the Treatment of Plaque-Type
Psoriasis
Connetics Corporation, Palo Alto, CA, announced that Phase
IV clinical study results evaluating the long-term efficacy
of a lower dosage of Soriatane (acitretin) indicate that
the low-dose regimens were effective and well tolerated
over a 6-month period in the treatment of moderate-to-severe
plaque-type psoriasis in adults. A poster highlighting the
results was presented at the 64th Annual Meeting of the
American Academy of Dermatology in San Francisco, CA.
The current Soriatane treatment
practice is to administer the maximum tolerable dose, from
25 mg to 60 mg per day, while also managing the dose-related
adverse effects, noted Jennifer Cather, MD, Modern Dermatology,
Baylor University Medical Center, Dallas, TX. The daily
low-dose regimen of 10 mg or 25 mg over a 6-month period
has demonstrated to be as effective when compared with the
current more aggressive treatment regimen. With these results,
Connectics anticipates that patients could begin initial
therapy with a low-dose 25 mg regimen of Soriatane and experience
a positive response with fewer adverse effects.
Information: http://www.connectics.com
CONTINUING EDUCATION
Clinical Symposium
on Advances in Skin & Wound Care
Mark your calendars now and plan to join us at Disney's
Coronado Springs Resort in Lake Buena Vista, FL, September
28 to October 1, 2006, for the 21st Annual Clinical Symposium
on Advances in Skin & Wound Care: The Conference for
Prevention and Healing. The deadline for submitting an abstract
or nominees for the Sharon Baranoski Founder's Award is
July 14, 2006. Click here
for more information.
ASSOCIATION NEWS
Wound, Ostomy and Continence
Nurses Week Is April 17-21
During the week of April 17-21, the Wound, Ostomy and Continence
Nurses Society will recognize the nurses who provide quality
and caring services to thousands of patients with wound,
ostomy, and continence (WOC) disorders. This population
includes more than 5 million Americans who suffer from chronic
wounds, a half million Americans who have ostomies and need
special care and teaching, and approximately 11 million
Americans with urinary and fecal incontinence.
Information: http://www.wocn.org
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