Foamix Announces Publication of AMZEEQ (minocycline) Topical Foam Long Term Safety Data for Treatment Up to 1 Year in Journal of Clinical and Aesthetic Dermatology
Posted on November 04, 2019 by Medtech[y] Staff
Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a specialty pharmaceutical company, announced today the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) in the Journal of Clinical and Aesthetic Dermatology (JCAD). Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ™ (minocycline) topical foam, which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
“Continuing from our earlier publication of Study FX2017-22 in the Journal of the American Academy of Dermatology, we are pleased that the Journal of Clinical and Aesthetic Dermatology has accepted these long-term safety data for publication,” said David Domzalski, Chief Executive Officer of Foamix. “I am proud of our entire R&D team for successfully executing on this important clinical program and achieving the approval of AMZEEQ by the FDA. Patients and physicians alike are rightly pushing for innovation in the treatment of acne as there have been very few genuinely novel treatments in recent years. With AMZEEQ, we hope to help address that need.”
Highlights from the Long-Term Safety Program:
The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ (minocycline) topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. The key findings from the study are as follows:
- Subject satisfaction with AMZEEQ treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12.
- Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with AMZEEQ. In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had “none” or “mild” signs and symptoms (erythema, dryness, hyperpigmentation, peeling, and itching), and no severe local tolerability scores were recorded.
- Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portions of each study. The most frequently reported treatment-emergent adverse event was nasopharyngitis (common cold). No serious drug-related adverse events were reported.
“We are extremely encouraged that our comprehensive safety evaluation of AMZEEQ has warranted publication in JCAD. AMZEEQ appears to be well tolerated, with an acceptable safety profile which is an important factor in the treatment of chronic, relapsing dermatological conditions such as acne,” said Dr. Iain Stuart, Chief Scientific Officer of Foamix.
INDICATIONS AND USAGE AMZEEQ™ (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.
IMPORTANT SAFETY INFORMATION Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.
Warnings and Precautions: Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
- Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
- Clostridium difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
- Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
- Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
- Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
- Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
- Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
- Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
- Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
- Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.
Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at 1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information.
About Acne Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs.
Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. For more information, visit www.foamix.com.