Promius PharmaceuticalsCeleus Pharmaceuticals
Dr. Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma, said the NDA is an important milestone in DFN-02's ongoing commitment to providing answers to unsatisfied needs. DFN-02 has shown in a multi-center, double-blind, placebo-controlled, double-blind, randomized trial with 107 volunteers (Clinicaltrials. gov # NCT02856802) that it can efficiently manage pains and associated signs during a seizure and reduces attack-related dysfunction.
Results from this trial show that there was a significantly higher percentage of DFN-02 volunteers with two hours of analgesia versus placebo: 43.8% (n=48) versus 22. DFN-02 was also significantly better than placingbo in relieving the patient's most troublesome symptoms (MBS), MBS, which included dizziness, photo-phobia, and phonophobia (70.7% vs. 39%).
The DFN-02 was well-tolerated with the following treatment-related side effects: dysgeusia (n = 4), site of administration soreness ( n = 2), thoracic pains, burn, rhinorrhoea and indisposition (n = 1 each), all moderate to modest. Once approved, the drug will be marketed by Promius Pharma. The DFN-02 is a novel in-tranasal aerosol formula that is currently patent pending in 11 jurisdictions (13 granted patent applications in total) and consists of 10 mg of Sumatriptan and Aegis Therapeutics, the LLC penetration enhancement technique known as Intravail®.
The DFN-02 is a novel intra-nasal formula under investigation for the topical management of aura and aura-related migraines. The DFN-02 formula allows rapid uptake of summatriptan into the circulatory system and has a pharmacokinetic similar to the subcutaneous administration of summatriptan. Cromicus Pharma is a 100% affiliate of Dr. Reddy's Laboratories, one of the biggest and most prestigious pharma groups in the United States.
Promius Pharma, with a strong business network and strong research and product pipeline through its mother organization, is dedicated to delivering new solutions that address the needs of dermatological and neurological patient care. Dr. Reddy's: Dr. Reddy's Laboratories Ltd. BSE: 500124, NSE: DRREDDY, NYSE: RDY is an Integrated Pharmaceuticals Group dedicated to delivering accessible and cutting-edge drugs for a healthy life.
With its three business units - Pharmaceutical Service & Active Ingredients, Global Generics and Proprietary Product - Dr. Reddy's provides a range of product and service offerings, which includes pharma therapeutic APIs, customized pharmaceuticals, generic drugs, bio-similars and differentiating formulas. Dr. Reddy's is active in global marketplaces. Exclusion of Liability: This news release may contain forward-looking and other forward-looking statement representations that are made on the basis of management's present beliefs and beliefs and involve known and unknown inherent and consequential risks und uncertainties that could cause results, performances or achievements to be materially different from those expressed express or implied by such statement.
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