Pharmaceutical Firm, Mayne Pharma (ASX: MYX) today (30 January 2019) announced the launch of its TOLSURA™ (SUBA®-itraconazole) 65mg capsule in the US. TOLSURA treats fungal infections including histoplasmosis (chronic cavitary pulmonary & non-meningeal histoplasmosis), aspergillosis (pulmonary & extrapulmonary, intolerant to amphotericin B therapy) and blastomycosis (pulmonary & extrapulmonary).
These infections have been mostly found in patients with high mortality rates and long-term health issues with the history of transplant (example bone marrow), cancer, HIV/AIDS, chronic rheumatic disorders.
All required approvals for TOLSURA™ were granted by US FDA (United States Food and Drug Administration) in December 2018. Mayne Pharma now has access to the US market with more than 60 products including four brands SORILUX (calcipotriene) foam, FABIOR (tazarotene) foam, TOLSURA (SUBA-itraconazole) capsules and DORYX MPC (doxycycline hyclate).
Mayne Pharma CEO, Mr. Scott Richards acknowledged the launch of TOLSURA as a new itraconazole form to improve the availability of poorly soluble drugs. For the promotion and marketing of TOLSURA, a specialized field sales team has been recruited.
Usage & Safety information for TOLSURA capsules:
It is an azole antifungal medicine which is used for the treatment of fungal infections in adult patients. It is not recommended for the treatment of onychomycosis and should not be substituted with other itraconazole products.
Treatment should be discontinued if signs of liver dysfunction or hearing loss or any neurologic symptoms occur.
Most rare side-effects observed are anorexia, albuminuria, abnormal hepatic function, abdominal pain, diarrhea, dizziness, decreased libido, edema, fever, fatigue, headache, hypokalemia, impotence, malaise, nausea, pruritus, rash and somnolence abdominal pain.
Negative-effects when subjects were treated:
- It can cause or exacerbate congestive heart failure (an adverse inotropic effect causing) as identified when dogs and healthy human volunteers were administered with itraconazole.
- A fatal arrhythmia was observed due to increased plasma concentration of some of these drugs.
- Renal/Hepatic impairment with varying degrees was observed when subjects were co-administered with colchicine, solifenacin, and fesoterodine.
- The strong and moderate dose of CYP2D6 inhibitors were contraindicated in intermediate metabolizers of CYP2D6.
Mayne Pharma is an ASX (Australian Stock Exchange) listed pharmaceutical firm under code MYX (listing date 29/06/2007), which develops and manufactures branded and generic products at its facilities at (Greenville) the USA and (Salisbury) Australia. The company provides manufacturing services and contract development to more than 100 clients worldwide. The company is located at 1538, main north road Salisbury South, Australia. Mr. Scott Richards is currently heading it as CEO and MD.
Mayne Pharma has a 30 year of experience in developing drug delivery system with many branded products established in the market such as Astrix, Doryx, Erymax, Kapanol, Lozanoc, etc. It has recently acquired 42 generic products from Teva/Allergan which significantly enhances a generic portfolio.
MYX’s shares traded at $0.815 (-1.212% intraday) with a market capitalization of circa $1.31 billion as on 30 January 2019.
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