Terbinafine

Ringworm fungal infections are common in the US and are becoming increasingly resistant to treatment – 6 questions answered

Retrieved on: 
Thursday, June 29, 2023

The World Health Organization considers antimicrobial resistance to be one of the most serious threats for global health.

Key Points: 
  • The World Health Organization considers antimicrobial resistance to be one of the most serious threats for global health.
  • Similar to the way bacteria have developed resistance to antibiotics, fungal infections throughout the world are becoming more drug-resistant and more deadly.

1. What is ringworm and how common is it?

    • However, a ringworm infection is a common infection of the skin caused by a fungus.
    • Experts state that about 20%-25% of the population will experience a ringworm infection at any given time.
    • Research shows that there are up to 40 types of fungus that can cause these ringworm infections, with the most common types being from the genuses Trichophyton, Microsporum or Epidermophyton.
    • Medical terms for ringworm are “tinea” and “dermatophytosis.” Tinea and dermatophytosis are synonyms for a contagious fungal infection of the skin.

2. How can you recognize ringworm?


    The hair, skin and nails of either fingers or toes are the likely landing spots for a ringworm infection. Signs and symptoms of an infection usually depend on which part of the body is affected, but generally may include hair loss and red, scaly, cracked skin. However, the most well-known sign that gives this infection its ironic and misplaced name – ringworm – is the hallmark ring-shaped rash.

3. How does ringworm spread?

    • Fungi can grow in two forms: yeasts, which are single round cells, and molds, which are made up of many cells forming long, thin, hairlike threads called hyphae.
    • Some of them can exhibit both forms of growth and thrive in decaying organic material like soil or a plant.
    • Ringworm occurs more frequently in tropical areas and during hot, humid summers.

4. How can you reduce the likelihood of getting it?

    • Some of the best ways to reduce or prevent a ringworm or other fungal infection include: – Wash hands with soap and warm water.
    • – Wear shoes and socks that are made of lightweight, breathable materials to reduce moisture.
    • – Avoid walking barefoot in wet or humid areas like locker rooms or public showers.

5. What treatments are there?

    • There are several treatment options, including antifungal medications prescribed by a physician or dermatologist or over-the-counter products sold as a cream or ointment.
    • Finally, in some cases a person may need to use antifungal shampoo and soap to clean themselves and sterilize bedding and clothing.

6. Why is antifungal resistance a growing problem?

    • Antimicrobial resistance, including antifungal resistance, is an ongoing global emergency.
    • Experts estimate that drug-resistant infections caused roughly 1.3 million deaths around the world in 2019.
    • Experts believe that inappropriate use of topical antifungal and corticosteroid medications is likely driving its spread.

MOB-015 is recommended for approval in EU: Moberg Pharma

Retrieved on: 
Wednesday, June 28, 2023

National approvals are expected to follow during upcoming months and timelines may vary between countries.

Key Points: 
  • National approvals are expected to follow during upcoming months and timelines may vary between countries.
  • "We are excited about the MOB-015 program, with its cutting-edge technology and the promising 76% mycological cure rate shown in the clinical trials.
  • We will initiate launch as quickly as possible following national approval, expecting to initiate launch preparations in Sweden before the end of the year.
  • Exact choice of countries will depend on time to national approval - which may vary.

Medexus Announces New License Deal for Topical Terbinafine

Retrieved on: 
Wednesday, March 22, 2023

The product, which Medexus will submit for Health Canada approval later this year, has been widely used in other markets to treat fungal nail infections.

Key Points: 
  • The product, which Medexus will submit for Health Canada approval later this year, has been widely used in other markets to treat fungal nail infections.
  • Medexus estimates the total value of the Canadian fungicides market to be C$88 million annually.
  • *
    “Terbinafine hydrochloride is an excellent strategic fit with our market leading product Rupall®.
  • If and when approved by Health Canada, Medexus will pay Polichem a quarterly low double-digit percentage royalty on net sales of the product, inclusive of supply price.

OgenaShield Pure Oxygen® HD Shampoo Now Available on Amazon

Retrieved on: 
Thursday, April 28, 2022

Ogena Solutions Pure Oxygen HD Shampoo is a 100% non-toxic, environmentally safe, and veterinarian-recommended way to clean and deodorize dogs, cats, horses and cattle.

Key Points: 
  • Ogena Solutions Pure Oxygen HD Shampoo is a 100% non-toxic, environmentally safe, and veterinarian-recommended way to clean and deodorize dogs, cats, horses and cattle.
  • This rinse-free, fragrance-free animal shampoo converts to oxygen and water vapor, leaves absolutely no active residue and works gently to relieve the animals itchy and irritated skin.
  • Works better than any oral meds or topical or other shampoos Ive tried in 6 years for animals with skin problems!
  • Ogena Solutions is a One Health organization focused on safeguarding animals, people and the environment from pathogens and infectious diseases.

Cipher Pharmaceuticals Announces Partner, Moberg Pharma's Regulatory Submission to FDA for North American Phase 3 Study

Retrieved on: 
Tuesday, March 22, 2022

The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America.

Key Points: 
  • The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America.
  • The study design builds on the experience gained from the previous Phase 3 studies.
  • Moberg Pharma will cooperate with the same CRO, lead investigator and successful sites from the previous North American study.
  • "We are pleased to see the continued progress that Moberg is making to commercialize MOB-015," said Craig Mull, Interim CEO of Cipher.

Moberg Pharma Meets Primary Endpoint in the European Phase 3 Study

Retrieved on: 
Thursday, June 25, 2020

STOCKHOLM, June 25, 2020 /PRNewswire/ --Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox.

Key Points: 
  • STOCKHOLM, June 25, 2020 /PRNewswire/ --Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox.
  • The pattern is consistent with the results from the North American Phase 3 study, with low complete cure rates despite the high mycological cure rates.
  • The primary endpoint was met in both studies, the proportion of patients achieving complete cure of their target nail.
  • This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.

Moberg Pharma Meets Primary Endpoint in the European Phase 3 Study

Retrieved on: 
Thursday, June 25, 2020

STOCKHOLM, June 25, 2020 /PRNewswire/ --Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox.

Key Points: 
  • STOCKHOLM, June 25, 2020 /PRNewswire/ --Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox.
  • The pattern is consistent with the results from the North American Phase 3 study, with low complete cure rates despite the high mycological cure rates.
  • The primary endpoint was met in both studies, the proportion of patients achieving complete cure of their target nail.
  • This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.

Moberg Pharma and Taisho Sign Exclusive License Agreement for MOB-015 in Japan

Retrieved on: 
Monday, September 30, 2019

STOCKHOLM, Sept. 30, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has signed an exclusive license agreement with Taisho Pharmaceutical Co., Ltd for development, registration and commercialization of MOB-015 in Japan.

Key Points: 
  • STOCKHOLM, Sept. 30, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has signed an exclusive license agreement with Taisho Pharmaceutical Co., Ltd for development, registration and commercialization of MOB-015 in Japan.
  • Moberg Pharma has entered into a license agreement granting Taisho Pharmaceutical Co., Ltd exclusive Japanese rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine.
  • Taisho will fund and conduct the development and registration activities in Japan, and will be marketing, distributing and selling MOB-015 in Japan upon completion of registration.
  • This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.

Moberg Pharma and Taisho Sign Exclusive License Agreement for MOB-015 in Japan

Retrieved on: 
Monday, September 30, 2019

STOCKHOLM, Sept. 30, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has signed an exclusive license agreement with Taisho Pharmaceutical Co., Ltd for development, registration and commercialization of MOB-015 in Japan.

Key Points: 
  • STOCKHOLM, Sept. 30, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has signed an exclusive license agreement with Taisho Pharmaceutical Co., Ltd for development, registration and commercialization of MOB-015 in Japan.
  • Moberg Pharma has entered into a license agreement granting Taisho Pharmaceutical Co., Ltd exclusive Japanese rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine.
  • Taisho will fund and conduct the development and registration activities in Japan, and will be marketing, distributing and selling MOB-015 in Japan upon completion of registration.
  • This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.

Moberg Pharma Completes Enrollment for MOB-015 Phase 3 Study in Europe

Retrieved on: 
Friday, March 22, 2019

STOCKHOLM, March 22, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has completed the recruitment of 452 patients with onychomycosis (nail fungus) for the ongoing MOB-015 phase 3 study in Europe.

Key Points: 
  • STOCKHOLM, March 22, 2019 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has completed the recruitment of 452 patients with onychomycosis (nail fungus) for the ongoing MOB-015 phase 3 study in Europe.
  • Phase 3 studies for MOB-015are progressing in Europe and North America evaluating the efficacy and safety of MOB-015, Moberg Pharma's proprietary topical formulation of terbinafine.
  • The enrollment to the European study has now been completed with 452 patients randomized at 48 sites in Europe.
  • Moberg Pharma has entered two license agreements for the commercialization of MOB-015 with Bayer AG in Europe and Cipher Pharmaceuticals in Canada.