|
What's New in Dermatology Drugs?
ATOPIC DERMATITIS/ECZEMA
Besides psoriasis, drugs such as Amevive and Raptiva, suggests
Dr. Leonardi, may find a place in treating other chronic inflammatory disorders,
such as atopic dermatitis. Once the drugs are used for psoriasis, you're likely
to see them used elsewhere, and chronic eczema will be one of the first paces.
As mentioned earlier, in atopic dermatitis the topical immunosuppressants
Protopic from Fujisawa and pimecrolimus (Elidel) from Novartis provide new treatment
options.
These agents are already "making a dramatic change," says Dr.
Kess. They work extremely well as maintenance therapies, he says, after initial
treatment with topical steroids.
Emmanuel Loucas, M.D.,Advanced Dermatology P.C. and The Center
for Laser and Cosmetic Surgery Manhattan and Long Island,
NY, looks for these two
drugs to be used in multiple skin conditions. They include alopecia areata,
graft versus host disease, lichen planus, pyoderma gangrenosum, sarcoidosis and
vitiligo.
ACNE AND ROSACEA
Unlike psoriasis, no new blockbuster treatments promise treatment
of acne in the near term. But treatments for rosacea are another story.
Azelaic acid gel 15% (Finacea) was approved early this month
for the treatment of the inflammatory papules and pustules caused by mild to moderate
rosacea. Finacea is the first new therapy for rosacea in more than a decade.
Berlex will launch its drug in the first quarter of this year.
A study for a systemic treatment for rosacea is also underway.
Last summer, CollaGenex Pharmaceuticals began Phase III clinical trials with its
doxycycline hyclate tablets, 20 mg. (Periostat). Galderma also launched a daily
cleanser, sodium sulfacetamide 10%, sulfur 5% (Rosanil), which is meant to complement
topical rosacea therapy.
For acne, advances involve the way
medications are combined,
says Dr. Feldman. Recognition is growing, he says, that topical retinoids
can help not only comedones but also inflammatory lesions. Clinicians may
use retinoids with topical and oral antibiotics to treat different types of acne.
Allergan's oral tazarotene (Tazorac) offers a shorter half-life
compared to Roche's isotretinoin (Accutane), says Dr. Leonardi. Because of
concerns about pregnancy and possibly depression when administering retinoids, any
drug that works in the same fashion but offers a shorter half-life would represent
an advance, he says.
In addition, Stiefel Labs just launched its new product to treat
inflammatory acne. Clindamyicin, 1% benzoyl peroxide, 5% (Duac
Topical Gel)
is approved for once-a-day dosing.
Currently, trials are underway on topical dapsone gel, says
Dr.Weinberg, also assistant clinical professor of dermatology at Columbia University
College of Physicians and Surgeons, New York. Anecdotal evidence indicates
that the antibiotic has an effect.
Photodynamic therapy (PDT) is another area that holds promise.
It involves administering a topical photosensitizing agent and then subjecting the
area to a blue light. Doing so causes the release of free oxygen radicals,
which can destroy the organism Propionibacterium acnes.
Some methods
involve high intensity blue light without the photosensitizing agent.
ACTINIC KERATOSIS
Already approved for genital warts, 3M's topical immunomodulator
imiquimod (Aldara) cream 5% is the most exciting treatment for actinic keratoses,
says Dr. Weinberg.
Phase III trials are nearing completion, and researchers are
studying several dose regimens, he says. (The literature also indicates that
the drug is successful for nodular and superficial basal cell carcinoma and Bowen's
disease, he says.) Diclofenac sodium (Solaraze gel 3%) from Bioglan Pharma, Inc.
is another effective approach. In theory, this NSAID inhibits the cyclooxygenase
pathway, which leads to decreased prostaglandin synthesis.
One benefit of this therapy is that patient compliance tends
to be better, says Dr. Loucas. It's much less irritating than traditional
fluorouracilmedications. That means patients are more likely to apply Solaraze
gel for longer periods of time. Recently approved by the FDA. Solarze represents
a "nice breakthrough," he says.
Carac (Dermik Laboratories), a diluted form of 5-fluorouracil,
can also be of benefit. Clinicians are also using PDT for actinic keratoses.
NON-MELANOMA
Clinicians are also studying Aldara to treat skin cancers, particularly
basal cell carcinoma, says Dr. Loucas. Several studies, he says, showed complete
resolution of skin cancer after 12 to 20 weeks of treatment.
Extending the PDT trand, Novartis Ophthalmics and QLT Inc. have
announced the start of patient enrollment in two Phase III clinical trials using
PDT with verteporfin for the treatment of multiple basal cell carcinomas.
A Phase II trial demonstrated preliminary safety and efficacy
of verteporfin at three light doses in patients with non-melanoma skin cancer with
multiple lesions.
The group of patients that was exposed to the highest light
dose had the best response rate. In this group, 98% of the assessed tumors
showed a complete clinical response following 6 months of initial treatment.
MELANOMA
For melanoma, current research focuses on vaccines to help broaden
the immune attack against the disease. Researchers are looking at three ways
to deliver antigen genes to the patient; into the blood using plasmid DNA; retrovirus;
and adenovirus, says Dr. Loucas. Immunization, he notes, will likely require
a combination of the three delivery systems.
Future development of vaccines, says Dr. Weinberg, may offer
a better alternative than interferon or interleukin as adjuvant therapy for advanced
disease.
MORE POTENTIAL ADVANCES
Besides drugs for these
major conditions, other agents
hold out hope for dermatology patients:
- Thalidomide for pyoderma gangrenosum and refractory aphthous ulcers
in the mouth.
-
Resiquimod (3M), a relative of imiquimod, for genital herpes.
-
In addition, although it's not new, hydrocortisone buteprate 0.1% (Pandel) for psoriasis
and atopic dermatitis will be relaunched in 2003 by CollaGenex.
GENE THERAPY FOR THE FUTURE
Though biologic therapies and other advances are likely to transform
dermatologists' prescribing patterns in the near term, gene therapy holds the promise
for long-range changes. Right now, gene therapy is in the "infant stage,"
says Dr. Lebowohl. Genetics is "always just over the horizon," says Datamonitor's
Mr. Pang.
While some rare genetic defects produce skin diseases, most
dermatology conditions are multlifactorial, says Joseph Fowler, Jr., M.D., clinical
professor of dermatology at the University of Louisville. That means genetic
therapy may be most beneficial, he says, for a small group of patients with those
genetic diseases.
BEYOND DERMATOLOGY
Drugs in development today may have far-reaching effects in
other areas. "The dermatology market," says the Datamonitor report, "represents
an effective route to other autoimmune diseases. Dermatological disorders
provide a prototypic model for other autoimmune diseases, in terms of disease pathogenesis,
and serve as an ideal proof-of-concept model
since drug effectiveness can be easily
assessed via changes in skin appearance. This will greatly increase the market
potential for new biologics in development for the treatment of dermatological disorders
|
Request an Appointment
