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PD0609 TxUpdate_Pipeline
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10:26 AM
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Therapeutics Update
In The Pipeline
Product News
There has been recent interest in the use of beta-blockers
for the treatment of severe infantile hemangioma. Now
Pierre Fabre Laboratories has announced the launch of a set
of clinical trials for a pediatric beta-blocker with the intention of obtaining NDA-approval (New Drug Application) both
for Europe and the USA.
New Laser on the Market. High speed hair reduction may now be possible, since Lumenis has
introduced the LightSheer Duet Diode Laser
System. According to the company, the
LightSheer Duet cuts hair removal treatment
times by up to 75 percent and improves patient
comfort. The system features two hair removal
systems on one platform, enabling physicians to
optimize permanent hair reduction anywhere on
the body, the company says. The platform also include the
LightSheer ET system, which Lumenis says is ideal for smaller or
bony anatomic areas.
Beta-blockers were first considered for the treatment of
hemangiomas by the University of Bordeaux’s Dr. Christine
Leaute-Labreze and colleagues. In a 2008 letter to the editor
in the New England Journal of Medicine(358:2649-2651) Dr.
Leaute-Labreze referenced a small study in which the beta
blocker propranolol effectively treated hemangiomas in 11
patients. Of the new beta blocker developed by Pierre Fabre,
Dr. Leaute-Labreze explains that it has been effective in several hundred children throughout the world. Nevertheless, she
notes, rigorous clinical trials are required to ascertain the
efficacy and tolerance of this new therapeutic strategy.
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"This is a major discovery that will bring true therapeutic advance
to patients affected by this highly apparent disease, which can be
very severe and can have a strong impact on their quality of life
and that of their parents,” says Jacques Fabre, General Manager of
Pierre Fabre Dermocosmetique in a statement. ■
Practical Dermatology
June 2009
PD0609 TxUpdate_Pipeline
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Therapeutics Update
OTC Combination. A new non-prescription option for hyperpigmentation is now available. Neutraderm recently unveiled HQRA OTC
formulation, a combination of Hydroquinone, Transretinol, and
Hydrocortisone Acetate they say was designed to inhibit the production of excessive skin pigment and melanin formation.
According to the company, the physician-dispensed product was
specifically formulated to replicate similar prescription products
and is ideal for use in conjunction with in-office procedures.
Meet Again. Reintroduced to the market, Clinac BPO 7% Gel is once
again available for treatment of mild to moderate acne. The vehicle
contains oil-absorbing Acrysorb technology, which Ferndale says
virtually “drinks up” excess sebum. The prescription formulation of
BPO 7% is oil-free, alcohol-free and fragrancefree. Ferndale is offering
patient mail-in rebates
for 50 percent off out-ofpocket costs or co-pays
up to $30.
A Close Shave. For patients seeking a close shave without bumps and
burns, consider dispensing Glytone’s Serious Shave Cream, a glycolic
acid-containing lotion (9.8 percent concentration) that provides
protection and lubrication during shaving. Glytone Serious Shave
Cream delivers a clean, close shave and also softens and conditions
the skin, helping to reduce razor burns, the company says.
NeXTRAC. Patients undergoing treatment with the XTRAC Laser may
be interested in the XTRAC Laser Post-Procedure Kit, a three-product
system from PhotoMedex that the company says speeds healing and
provides comfort and protection to skin post-treatment. Included in
the kit is the Complex Cu3 Intensive Tissue Repair Crème, Complex
Cu3 Post-Laser Lotion, and Ti-Silc Sheer SPF45. Products feature
GHK Copper Peptide Complex, which the company says positively impacts collagen
deposition, tensile strength, and
anglogenesis to enhance healing for
patients treated for psoriasis/vitiligo, cosmetic surgery, and hair
transplant procedures. ■
June 2009
FDAACTIONS
Simponi Cleared. Centocor’s golimumab (Simponi) got the FDA
nod for the treatment of chronic immune types of arthritis.
For more on this new anti-TNF agent, see “Recent
Developments,” p. 6
Dysport Approved. The FDA
approved Ipsen’s Dysport, to
be marketed for cosmetic indications by Medicis, for treatment of glabellar lines. For
more on this new abobotulinum toxin A therapy, see coverage in this issue.
Boxed Warning for Botulinum Toxin. In follow-up to an ongoing
safety review, FDA announced that makers of botulinum toxin
treatments are now required to add a boxed warning about
adverse events that may occur if the effects of the toxin spread
beyond the injection site. These products include Allergan's
Botox (botulinum toxin type A), Solstice Neurosciences'
Myobloc (botulinum toxin type B), and Medicis' and Ipsen's
Dysport (abobotulinumtoxin A).
The agency reviewed reports of adverse events dating back to
1989, according to Ellis Unger, acting deputy director at the
FDA, and found evidence that the toxins may travel beyond the
injection site to weaken or paralyze muscles used for breathing
and swallowing. In adults, most reports of distant spread of botulinum toxin occurred in patients who received Botox or Myobloc
for unapproved use in spasticity, or for approved use in cervical
dystonia. The FDA said that it could not attribute several deaths
in adults to botulinum toxin because patients also had preexisting conditions. The agency noted that it has identified "no
definitive serious adverse-event reports of distant spread of
toxin effect associated with dermatologic use of Botox" at
approved doses. ■
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