Rehovot, Israel, March 20, 2012 --(PR.com
)-- Foamix, a clinical stage specialty pharmaceutical company, announced today the successful completion of the Phase II clinical trial of Minocycline foam in Impetigo patients. Minocycline Foam has shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA).
The randomized double blind Phase II clinical study, conducted in pediatric patients with impetigo, was designed to assess the efficacy, safety and tolerability of two strengths of the Minocycline Foam. Patients received the foam twice daily for 7 days; and they were checked again on day 14.
Robust efficacy was demonstrated in both 1% and 4% strength doses in this randomized, double-blind, dose-ranging study enrolling 32 patients ages 2 to 15. Clinical response at the end of the treatment was 92% and 100% respectively for the low or high doses; and all patients (100%) showed success on day 14.1 Notably, 80% of the total patients cured or improved significantly after 3 days of treatment.
Eight patients had MRSA and in all of them the bacterial infection was eradicated on day 7.
No drug related side effects were recorder in any of the patients throughout the study.
“These results are excellent; especially considering this study is the first to treat patients with topical Minocycline. The results confirm the efficacy of our Minocycline Foam in skin infections. It is also significant that our Minocycline Foam was well-tolerated and that there was no evidence of clinical safety concerns since one of the persistent barriers to the development of new classes of antibiotics has been the issue of patient safety,” commented Dov Tamarkin, Foamix CEO. “We intend to aggressively pursue the development of our Minocycline Foam as a first-line treatment for a range of skin conditions, including Acne, Rosacea, Impetigo and other skin infections.”
Key Features of Foamix’s Minocycline Foam
- Minocycline is an extremely unstable compound, which currently exists only in oral dosage forms. Foamix successfully developed a stable, patient-friendly topical foam containing up to 4% Minocycline.
- The topical administration of Minocycline Foam provides concentrated drug delivery to the infected lesion site, and leads to rapid cure, whilst avoiding the side effects common in the oral Minocycline treatment.
- With a twice daily application, Minocycline Foam can lead to better patient compliance compared with other treatment options.
- Foam is a user friendly dosage form which spreads evenly and absorbs easily without rubbing. This offers a great advantage when treating open wounds especially in small children.
Minocycline Foam Targets $1 Billion a Year Market
Foamix’s first-in-class topical Minocycline Foam is directed for the treatment of Acne, Rosacea and Skin infections, such as Impetigo and is currently being studied in Phase II clinical trials in Rosacea and Acne.
Targeting a patient population of more than 30 million patients in the U.S., this drug may become a blockbuster in dermatology, with annual peak sales in excess of $1 billion. Foam is preferred by users for topical treatment, due to its ease in spreading and quick absorption. The current sales of oral Minocycline in the U.S. exceed $1 billion.
1 Success criteria – based on the recently approved Altabax (GSK)
Impetigo is a highly contagious superficial bacterial infection of the skin that afflicts approximately 1 million patients, primarily infants and children, in the US annually. Most cases are caused by Staphylococcus aureus, Streptococcus pyogenes, or a mixture of both organisms. Methicillin-resistant S. aureus (MRSA) is found with increasing frequency in this population. Impetigo is currently being treated with antibiotic ointments, to which bacteria develop resistance.
Replace Oral with Topical
Minocycline, which is currently available only in oral tablets and capsules. A survey recently conducted among U.S. dermatologists revealed that even though 95% of dermatologists prescribe oral Minocycline, the majority of them (89.7%) are concerned about the oral side effects which include upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, mouth sores, headache and vomiting. Due to these side effects, in 2009 the FDA added oral Minocycline to its Adverse Event Reporting System (AERS); a list of medications under investigation by the FDA for potential safety issues.
The survey revealed that 77% of dermatologists would prefer prescribing a Topical Minocycline drug over the existing oral Minocycline, assuming it was safe, effective and approved by FDA.
It is now shown that topical Minocycline Foam offers a safe and effective alternative to the current oral drug.