Hyderabad, India's Dr. Reddy's Laboratories ($RDY) won FDA approval for its generic ZembraceSymTouch injection for adults with migraines that are inadequately managed with existing treatment regimens, such as oral medications.
The subcutaneous combination product consists of a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan.
"We are pleased to have received FDA approval for ZembraceSymTouch," said Raghav Chari, the executive vice president of Dr. Reddy's proprietary products group, in a statement. "ZembraceSymTouch is the first branded product in our Neurology portfolio. Migraines affect millions of patients. Many of these patients have busy lives and quick pain relief is critical to help them manage through their daily routines. In many cases, migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. ZembraceSymTouch is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option."
ZembraceSymTouch will be marketed in the U.S. by Promius Pharma, a wholly owned specialty company of Dr. Reddy's.
Analysts are expecting annual sales of $40 million to $50 million, reports Indian business news outlet the Economic Times, pushing Dr. Reddy's shares up almost 4% on the New York Stock Exchange, where they now stand around $45. The company reported net income of $350 million on revenues of $2.36 billion for the year ending March 31, 2015.
ZembraceSymTouch enters the crowded sumatriptan succinate generic market, which consists of a plethora of other medications, according to the FDA's database of approved drugs. Competitors include oral and subcutaneous meds from the likes of Sun Pharmaceutical Industries, Mylan ($MYL) and Teva ($TEVA), which also boasts the only version delivered using iontophoresis, or a local electrical current.
GlaxoSmithKline ($GSK) offers the only intranasal option. Soon Avanir's just-approved Onzetra, which delivers 22 mg of sumatriptan intranasally using the Xsail Breath Powered Delivery Device, will hit the market.
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