Onafhankelijk Nederlands Hyperhidrosis Forum

Ik heb een tijdje geleden al contact opgenomen met sofdra maar zoals wel vaker bij dit soort bedrijven krijg ik simpelweg geen antwoord. Jammer. :duimol

Sofdra Approved for Primary Axillary Hyperhidrosis
Avatar photoDiana Ernst, RPh | June 21, 2024

Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of acetylcholine receptors that are located on sweat glands.
The Food and Drug Administration (FDA) has approved Sofdra™ (sofpironium) topical gel, 12.45% for the treatment of primary axillary hyperhidrosis in adults and children 9 years of age and older.


Sofpironium bromide is a structural analogue of glycopyrrolate, an anticholinergic agent. It is designed to selectively bind to M3 muscarinic acetylcholine receptors in sweat glands, thereby inhibiting sweat production.

The approval was based on data from the randomized, double-blind, vehicle-controlled Cardigan I (ClinicalTrials.gov Identifier: NCT03836287) and Cardigan II (ClinicalTrials.gov Identifier: NCT03948646) trials. The studies evaluated the efficacy and safety of sofpironium topical gel in 701 patients aged 10 years and older with primary axillary hyperhidrosis. Patients were randomly assigned 1:1 to receive either sofpironium gel or vehicle applied to each axilla once daily at bedtime for 6 consecutive weeks.

In Cardigan I, the mean Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax) score at baseline was 3.5. Median gravimetric sweat production (GSP) over 5 minutes at baseline was 214.1mg in the sofpironium arm and 228.6mg in the vehicle arm.

Results showed 49% of patients treated with sofpironium had at least a 2-point improvement in HDSM-Ax score from baseline to day 43 compared with 29% of those who received vehicle (treatment difference, 18% [95% CI, 8-29]). Moreover, the sofpironium arm experienced a greater change from baseline in GSP (mg/5 minutes) compared with the vehicle arm (-128 vs -100).

In Cardigan II, the mean HDSM-Ax score at baseline was 3.6. Median GSP over 5 minutes at baseline was 207.7mg in the sofpironium arm and 231.1mg in the vehicle arm.

Findings showed 64% of patients treated with sofpironium achieved at least a 2-point improvement in the HDSM-Ax score from baseline to day 43 compared with 48% of those who received vehicle (treatment difference, 17% [95% CI, 6-27]). The sofpironium arm also demonstrated a greater change from baseline in GSP vs the vehicle arm (-143 vs -134).


The most common adverse reactions reported with sofpironium included dry mouth, blurred vision, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation.

Sofdra is supplied in a 50mL bottle with a metered dose pump and applicator. One full pump delivers 72mg of sofpironium in 0.67mL of gel. The product is expected to be available in the fourth quarter of 2024.

References:
FDA approval of Sofdra™ – the first new drug for primary axillary hyperhidrosis. News release. Botanix Pharmaceuticals. June 20, 2024. https://botanixpharma.com/fda-approves-sofdra-topical-gel/.
Sofdra. Package insert. Botanix; 2024. Accessed June 21, 2024. www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf.

Bron: https://www.empr.com/home/news/sofdra-approved-for-primary-axillary-hyperhidrosis/

ECCLOCK heet nu dus sofdra en is goedgekeurd door de FDA in de USA. Ik zie het nog niet zo snel naar europa komen want wij hebben hier al axhidrox wat feitelijk hetzelfde is. Meer info op https://www.sofdra.com

ECCLOCK is nu ook goedgekeurd in Korea las ik op het wereldwijde web. Er komt ook nog een 15% glyco-gel aan van botanix. Zie: https://botanixpharma.com/sofpironium-bromide/

Let wel, dit is allemaal in het buitenland, Ik zie het nog niet zo snel naar Nederland komen. Ik denk dat wij het hier voorlopig met axhidrox 1% glyco creme moeten doen; deze is beschikbaar nu op recept in NL.

Op de site van horizonscangeneesmiddelen staat nu bij therapeutische waarde van ECCLOCK-gel het volgende:

[quote]Er is een marginaal effect geconstateerd plus een heel aantal bijwerkingen (4 x zoveel milde bijwerkingen). De verwachting is dat de voorkeur aan botox gegeven zal worden.[/quote]

WTF? Botox lijkt me aardig achterhaald met de huidige nieuwe behandelmethodes tegen overmatig zweten. Daarnaast is botox natuurlijk maar van tijdelijke aard en relatief pijnlijk. Wedden dat als de ECCLOCK-gel eenmaal naar Nederland komt dit NIET vergoed gaat worden? Het moet echt niet gekker worden. Elk nieuw medicijn is experimenteel en voldoet niet aan de stand van de wetenschap bla bla.... :boos

Kennelijk is ECCLOCK gel nu ook geregistreerd voor Europa want op https://www.horizonscangeneesmiddelen.nl/geneesmiddelen/sofpironium-bromide-stofwisseling-en-endocrinologie-stofwisseling_en_endocrinologie_overig/versie1 staat het beschreven.

Er staat wel bij dat het niet in de verwachting ligt dat het ook zal worden gebruikt tegen hyperhidrosis noch dat het vergoed zal worden. Duh... wat wordt tegenwoordig nou wel vergoed ? Bah.

Naja klik op de link en lees zelf.
We houden het in de gaten.

Das inderdaad prijzig. Maar het is nieuw en zal waarschijnlijk wel iets gaan zakken tegen de tijd dat het eindelijk in Europa beschikbaar is hoop ik. Als het echt goed werkt kan het de moeite waard zijn..... zal wel weer niet vergoed worden door de ziektekostenverzekeraars. :duimol

Flink geprijsd zo te zien:

[quote]The NHI listed drug price for ECCLOCK® in Japan is ¥243.70 per gram, which is ¥4,874.00 (USD $46.47) for a 20 gram bottle or approximately a two-week supply.[/quote]

[url]https://www.globenewswire.com/news-release/2020/11/18/2129056/0/en/Brickell-Biotech-Announces-Launch-Date-for-Sofpironium-Bromide-Gel-5-ECCLOCK-in-Japan-by-its-Development-Partner-Kaken-Pharmaceutical.html[/url]

Nee. Ik heb het aan onze dermatoloog Wim Venema gevraagd. Hij zei dat het voor oksels en liezen met name geindiceerd is. Handen voeten niet omdat de huid dikker is.

Begrijp ik het goed dat je deze gel over je gehele lichaam kunt aanbrengen?

Sofpironium bromide is een variant van glycopyrronium die we natuurlijk allemaal kennen als (orale) pillen tegen overmatig zweten over het gehele lichaam cq plekken die niet anders te behandelen zijn. Dit is een veelbelovende gel als je het mij vraagt.....

ECCLOCK Gel 5% Approved in Japan for the Treatment of Primary Axillary Hyperhidrosis
(Ref: Kaken)
September 25th, 2020
Tags: Press Release Ecclock Brickell Biotech Kaken Marketing & Sales Regulatory Affairs

Tokyo, September 25, 2020 - Kaken Pharmaceutical Co., Ltd., ("Kaken") announced that it has obtained approval of ECCLOCK® Gel 5% (INN: sofpironium bromide, code name: BBI-4000, "ECCLOCK®") in Japan for primary axillary hyperhidrosis.

ECCLOCK® is the first topical product in Japan approved for the treatment of primary axillary hyperhidrosis, which is classified as an anticholinergic agent that inhibits the action of acetylcholine, a neurotransmitter. Acetylcholine is thought to induce sweating by binding to muscarinic receptors at the sweat glands. Sofpironium bromide, an active ingredient of ECCLOCK®, inhibits the binding of acetylcholine by binding to muscarinic receptors in the eccrine sweat glands that cause hyperhidrosis, thereby reducing sweating. Applying it once a day to both the axillae can be effective. An applicator (application tool) included with the container-closure system of the product allows the drug application without the hands touching the product.

In March 2015, Kaken acquired the exclusive rights to the development, manufacture, and marketing in Japan and certain other Asian countries from Brickell Biotech, Inc., based in Colorado, USA ("Brickell"), for sofpironium bromide, and has developed as a topical drug product in Japan. ECCLOCK® Gel 5% is approved based on the results of the Phase 3 study in Japan. The multicenter, randomized, double-blind, vehicle controlled confirmatory study was designed to evaluate the efficacy and safety of ECCLOCK® Gel 5% vs. vehicle administered for 6 weeks in 141 and 140 subjects with primary axillary hyperhidrosis. The results showed that the primary endpoint—the percentage of subjects with an HDSS of 1 or 2 and ≥50% reduction in the gravimetric sweat production from baseline to end of treatment (week 6) for both axilla—showed significant improvement in ECCLOCK® Gel 5% group compared to the vehicle group. The main adverse events related to study drug were dermatitis, erythema, or pruritus at the application site.

In the meantime, Brickell plans to initiate a Phase 3 study in the United States in the fourth quarter of 2020.

Kaken will contribute to improving the quality of life for more patients by providing a new treatment option for primary axillary hyperhidrosis.

About Primary axillary hyperhidrosis

A condition that involves heavy sweating under the armpits caused by heat, stress, or occurring without such causes, and interferes with daily life and work.

About HDSS

Hyperhidrosis disease severity score (HDSS) is the scale to assess the severity of hyperhidrosis based on subjective symptoms and is a score that is classified into four categories from 1 to 4, depending on the patient's reported outcomes. A score of 3 or 4 is considered an indicator of severe illness.1

Strutton DR, et al.: J Am Acad Dermatol 2004; 51(2): 241-248.

Bron: https://www.firstwordpharma.com/node/1760439?tsid=33

Toegestaan in Japan dus al, nu wachten op de FDA in de USA en dan hopelijk snel naar Europa! :ja :banaan