Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA, warrants SNOAW), a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care, today announced the results of
a clinical study evaluating the impact of SebuDerm™ (topical
hypochlorous acid) gel in the treatment of mild to moderate facial
and scalp seborrheic dermatitis.
In a 25-patient study, conducted by Zoe Draelos, MD; and
president of Dermatology Consulting Services in High Point, North
Carolina, two key metrics were utilized in assessing efficacy of
SebuDerm; the first being the investigator’s global assessment
(IGA) of efficacy improvement in appearance and symptoms from
baseline; and secondly, the subject global assessment (SGA) of
improvement in itching, burning and stinging. No adverse
effects were reported and overall treatment was well tolerated by
the subjects.
Author of the study, Zoe Draelos, MD, commented, “Seborrheic
dermatitis is a common condition afflicting men and women of all
ages that is challenging for dermatologists to treat. While
treatment options exist, recurrence is common and few options
exist for disease maintenance. A new addition to the
dermatologist’s armamentarium will be welcomed.”
The IGA of efficacy improvement from baseline was 33% at day 14
and 52% at day 28. The SGA of efficacy improvement from
baseline was 62% through day 28.
Dr. Draelos’ clinical study poster is being presented at 13th
Annual Maui Dermatology Conference in Maui, Hawaii on March 20-24,
2017. The company received a new 510(k) clearance from the
U.S. Food and Drug Administration (FDA) for the company’s SebuDerm™
Gel as a prescription product, intended to manage and relieve the
burning, itching, erythema, scaling and pain experienced with
seborrhea and seborrheic dermatitis in December 2015.
U.S. commercialization is underway via Sonoma’s dermatology
division IntraDerm Pharmaceuticals’ 30-plus-person direct sales
team. Sonoma is also in discussions with prospective
international distributors and partners to bring this advanced
technology to dermatology patients throughout the globe, including
Asia, Latin America and the Middle East.
“Our new SebuDerm gel adds a valuable tool to the
dermatologist’s bag when it comes to combatting both seborrhea and
seborrheic dermatitis,” said Jeffrey Day, president of IntraDerm
Pharmaceuticals. “Nearly a quarter of the general population is
afflicted with seborrheic dermatitis and we hope to impress our
physician customers with our terrific new treatment option in
SebuDerm.”
Seborrheic Dermatitis Market SizeIt is
estimated that 25% of the general population has seborrheic
dermatitis. Although the etiology of seborrheic dermatitis is not
entirely understood, most experts share the belief of Bruce
Strober, M.D., Ph.D., co-director of the psoriasis and psoriatic
arthritis center at New York University Medical Center, who says,
“The disease may be triggered by environmental factors, but there
is a strong immune predisposition.” The disease is far more
prevalent in patients with HIV, neurologic disorders, elderly
patients and infants.
According to JAMA Pediatrics, an industry healthcare journal,
seborrheic dermatitis is a common complaint brought to
pediatricians. Also known as “cradle cap” in infants, “dandruff” in
adolescents, seborrheic dermatitis is also found in the face, scalp
and chest areas in adults. It is believed this condition is
triggered by Malassezia yeasts. Treatment has supported a billion
dollar market for over-the-counter treatments.
Current Treatment OptionsStudies have also
shown a causative role of the yeast-like fungus Pityrosporum in the
development of seborrheic dermatitis, notes Joel Schlessinger,
M.D., a dermatologist in private practice in Omaha, Nebraska, and
president emeritus of the American Society of Cosmetic Dermatology
& Aesthetic Surgery.
Dr. Schlessinger advocates the use of both oral ketoconazole
(weekly for six to eight weeks) and a topical foam to treat the
underlying pityrosporum infection. In addition, newer formulations
of corticosteroids, like clobetasol and betamethasone, he says,
“have markedly changed the treatment of scalp psoriasis and
seborrheic dermatitis. Before these were available there were few
palatable options for these conditions, but now the treatments are
quite ‘patient friendly.’ Older treatments such as Derma-Smoothe
F/S and other tar-based shampoos are clearly a challenge for
patients and often result in poor results due to compliance
issues.”
Current therapies include the use of a topical
ketoconazole-containing agent. If that is not effective, then
dermatologists may step up to a topical corticosteroid, with lower
potency on the face, higher potency on the scalp. Another popular
option is the use of topical immunomodulatory drugs, like
tacrolimus and pimecrolimus. These agents have been found to be
safe and effective for seborrheic dermatitis on the face. The
downside is that they burn and sting. If there is not a
reimbursement issue, dermatologists often prescribe these drugs as
first-line therapy.
About Sonoma Pharmaceuticals, Inc.Sonoma is a
specialty pharmaceutical company that develops and markets unique
and effective solutions for the treatment of dermatological
conditions and advanced tissue care. The company’s
products, which are sold throughout the United States and
internationally, have improved outcomes for more than five million
patients globally by reducing infections, itch, pain, scarring
and harmful inflammatory responses. The company's headquarters are
in Petaluma, California, with manufacturing operations in the
United States and Latin America. European marketing and sales
are headquartered in Roermond, Netherlands. More information can be
found at www.sonomapharma.com.
Forward-Looking StatementsExcept for historical
information herein, matters set forth in this press release
are forward-looking within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995,
including statements about the commercial and technology progress
and future financial performance of Sonoma Pharmaceuticals,
Inc. and its subsidiaries (the “Company”). These forward-looking
statements are identified by the use of words such as “believe,”
“achieve,” and “strive,” among others. Forward-looking statements
in this press release are subject to certain risks and
uncertainties inherent in the Company’s business that could cause
actual results to vary, including such risks
that regulatory clinical and guideline developments may
change, scientific data may not be sufficient to meet
regulatory standards or receipt of required regulatory clearances
or approvals, clinical results may not be replicated in actual
patient settings, protection offered by the
Company’s patents and patent applications may be challenged,
invalidated or circumvented by its competitors, the available
market for the Company’s products will not be as
large as expected, the Company’s products will not be able to
penetrate one or more targeted markets, revenues will not be
sufficient to fund further development and clinical studies, the
Company may not meet its future capital needs, as well as
uncertainties relative to varying product formulations and a
multitude of diverse regulatory and marketing requirements in
different countries and municipalities, and other risks detailed
from time to time in the Company’s filings with the Securities and
Exchange Commission including its annual report on Form 10-K for
the fiscal year ended March 31, 2016. The Company disclaims
any obligation to update these forward-looking statements, except
as required by law.
Sonoma Pharmaceuticals®, IntraDerm Pharmaceuticals®, SebDerm™
and Microcyn® Technology are trademarks or registered trademarks of
Sonoma Pharmaceuticals, Inc. All other trademarks and service marks
are the property of their respective owners.
Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.
Dan McFadden
VP of Public and Investor Relations
(425) 753-2105
dmcfadden@Sonomais.com
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