The discovery and development of halogenated
corticosteroids in the second half of the 20th century revolutionized the
treatment of inflammatory and allergic skin conditions. Among these
advancements, Synalar, a topical corticosteroid based on fluocinolone
acetonide, emerged as a milestone in dermatology. First synthesized in 1957 by
the pharmaceutical laboratory Syntex, based in Palo Alto, California, and
developed at its research center in Mexico City, Synalar marked a turning point
in the management of skin disorders. This article reviews the history of
Synalar, its impact on medicine, and its enduring relevance in the
pharmaceutical market.
Origins: Syntex and Innovation in Corticosteroids
In the 1950s, corticosteroid research was in full
swing, driven by the discovery of cortisone and its therapeutic applications.
However, early corticosteroids had limitations, such as low potency and
significant systemic side effects when applied topically. Syntex, a pioneering
company in steroid chemistry, set out to overcome these barriers. Founded in
1944 in Mexico and later established in Palo Alto, Syntex had already gained
recognition for its advances in synthesizing steroid hormones, including
progesterone.
In 1957, Syntex scientists, working in their research
department in Mexico City, successfully synthesized fluocinolone acetonide, a
synthetic derivative of hydrocortisone. The key to their innovation was the
incorporation of a fluorine atom at position 9 of the steroid nucleus,
significantly enhancing the compound’s potency. This chemical modification not
only boosted the corticosteroid’s anti-inflammatory, antipruritic, and
vasoconstrictive activity but also minimized systemic absorption, making it
ideal for topical use. The resulting compound was named fluocinolone acetonide,
and Syntex marketed it under the brand name Synalar in 1959, becoming one of
the first halogenated corticosteroids available on the market.
Synalar: A Breakthrough in Dermatological Treatment
Synalar was initially introduced in concentrations
ranging from 0.01% to 0.025%, designed to treat a wide variety of inflammatory,
allergic, and pruritic skin conditions. Its ability to relieve symptoms such as
redness, itching, inflammation, scaling, and crusting quickly made it a drug of
choice for disorders like atopic dermatitis, psoriasis, eczema, contact
dermatitis, lichen planus, and discoid lupus erythematosus.
Fluocinolone acetonide, classified as a potent grade
III corticosteroid, offered superior efficacy compared to earlier
corticosteroids like hydrocortisone, thanks to its greater affinity for
glucocorticoid receptors and localized action. Additionally, its formulation in
cream, ointment, solution, shampoo, and oil allowed it to meet diverse clinical
needs, from scalp applications to the treatment of extensive lesions. Synalar’s
versatility, combined with its efficacy, positioned it as a leader in the
dermatological market.
Synalar also stood out for its use in combinations
with other active ingredients, such as neomycin (Synalar-Neo), an antibiotic
that addresses secondary bacterial infections in dermatoses, or with agents
like ciprofloxacin in otic preparations. These formulations expanded its
therapeutic scope, including conditions like external otitis and inflamed
hemorrhoids.
Impact and Evolution in Dermatology
The launch of Synalar marked a paradigm shift in
dermatology. Before its arrival, treatments for inflammatory skin conditions
were limited and often required systemic therapies with higher risks of adverse
effects. Synalar provided a safe and effective alternative, enabling physicians
to treat localized conditions with minimal systemic absorption. Its success
inspired the development of other halogenated topical corticosteroids,
solidifying Syntex’s position as a leader in the pharmaceutical industry.
Over the decades, Synalar remained relevant due to its
proven efficacy and safety profile when used as directed. Clinical studies and
reviews have supported its utility in managing recalcitrant dermatoses,
although clear precautions have been established, such as avoiding prolonged
use in children, on large areas, or under occlusive dressings, due to risks of
skin atrophy, hypopigmentation, or suppression of the
hypothalamic-pituitary-adrenal axis.
The drug has also undergone commercial adaptations. In
addition to its classic presentations, Synalar has been marketed under names
like Fluocid Forte, Gelidina, and Synalar Gamma, and in combinations such as
Synalar Rectal for hemorrhoids. Its availability in various concentrations and
formats has allowed for personalized treatment based on the severity of the
condition and the patient’s sensitivity.
Current Relevance and Legacy
More than six decades after its launch, Synalar
remains a cornerstone in dermatology. Despite the emergence of new topical
corticosteroids and biologic treatments, Synalar’s cost-effectiveness,
versatility, and efficacy keep it a preferred choice for physicians and
patients. In many countries, it is available both in generic form and under
commercial brands, ensuring its accessibility.
Synalar’s legacy extends beyond its clinical impact.
It represents Syntex’s success as a pioneer in steroid research and serves as
an example of how chemical innovation can transform medical practice.
Synalar is, therefore, much more than a medication: it
is a symbol of progress in dermatology. From its synthesis in 1957 to its
continued use in the 21st century, it has alleviated the suffering of millions
of patients with inflammatory and allergic skin conditions. Despite the
challenges associated with topical corticosteroids, its efficacy, versatility,
and safety, when used correctly, have cemented its status as a leader in its
field.
Synalar’s impact endures, not only in pharmacies and
clinics but also in the history of pharmaceutical innovation, proving that a
well-executed discovery can withstand the test of time.
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