Dr. Reddy’s files NDA for anti-migraine candidate
DFN-02 is a novel intranasal spray formulation which contains Sumatriptan 10mg and Intravail which contains DDM i.e. 1-On-Dodecyl-β-D-Maltopyranoside, a chemically synthesizable transmucosal absorption enhancement agent.
This combination makes absorption of Sumatriptan in the blood circulation faster than the currently available subcutaneous Sumatriptan. In the clinical trials, DFN-02 reported more rapid absorption profile than commercially available intranasal Sumatriptan 20mg. The safety and tolerability were also comparable to subcutaneous sumatriptan.
Sumatriptan (brand – Imitrex) has been a very effective and successful antimigraine drug for many years. Sumatriptan injection had global sales of approximately GBP168mn ($237mn) of which GBP77mn ($109mn) were in the United States in 2017.
Sumatriptan is available in several formulations (tablets, injections and spray) and there are already several generic companies in this market. The competition is quite less in the spray and that should benefit Dr Reddy’s if it gets final approval from the USFDA. DFN-02 spray will be commercialized by Promius Pharma.
While the clinical trial data has been promising, the sales are not likely to be huge as Sumatriptan succinate, a generic drug in similar indication is available in different formulations. Generic Sumatriptan spray is also available from Feb-2016. Dr Reddy’s NDA is banking on the use of Sumatriptan 10mg with the chemically synthesizable transmucosal absorption enhancement agent. Overall Sumatriptan Nasal Spray market was pegged to be $62mn in 2015, so it is not a huge market to start with. We do not keep very high hopes for this NDA candidate.