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NDA –Sefelsa (gabapentin) Extended Release Tablets – formerly Serada

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GABAPENTIN


Sefelsa (gabapentin) Extended Release Tablets – formerly Serada

Company: Depomed, Inc.
Treatment for: Menopausal Hot Flashes

Sefelsa (gabapentin) is an investigational extended-release formulation of gabapentin in development for the treatment of menopausal hot flashes.

  • Depomed Provides Update on Sefelsa FDA Advisory Committee – March 4, 2013
  • Depomed Announces Serada NDA Acceptance and FDA Advisory Committee Meeting – October 15, 2012
  • Depomed Announces Submission Of Serada NDA – August 17, 2012
  • Depomed Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes – April 18, 2012

NEWARK, Calif., March 4, 2013

Depomed, Inc., a specialty pharmaceutical company, announced today that the Reproductive Health Drugs Advisory Committee (RHDAC) of the U.S. Food and Drug Administration (FDA) voted 2-12 against approval for Sefelsa, Depomed’s investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause.  Sefelsa is the proposed trade name for the medication and was formerly referred to as Serada.  Based on the outcome of committee meeting, the company will not have a conference call today as previously indicated.

“Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with a growing franchise of treatments for pain and potentially other CNS indications. With revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year, we believe that 2013 has the potential to be a landmark year in our company’s history,” said Jim Schoeneck, President and Chief Executive Officer of Depomed.  “We recognize and appreciate the concerns that were raised by the members of the Advisory Committee. Based on today’s meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high.  Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate.”

Data presented at today’s Advisory Committee Meeting included results from the Phase 3 clinical program, which enrolled 1706 patients in three studies.

The FDA will consider the Advisory Committee recommendation in its review of the New Drug Application (NDA) for Sefelsa that Depomed submitted on July 31, 2012, though the FDA is not bound to follow it.  The Prescription Drug User Fee Act (PDUFA) date for Sefelsa is May 31, 2013. The PDUFA date is the goal date for the FDA to complete its review of the NDA.

About Vasomotor Symptoms

Vasomotor symptoms include hot flashes and night sweats.  A hot flash is a sudden flushing and sensation of heat caused by dilation of skin capillaries. Currently, the leading prescription drug product for the treatment of hot flashes associated with menopause is hormone replacement therapy (HRT).  HRT involves the administration of the hormone estrogen, either alone or in combination with the hormone progestin.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN).  Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults.  Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States.  Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food.  Additional information about Depomed may be found on its website, www.depomed.com.

 Gabapentin (Neurontin) is a pharmaceutical drug, specifically a GABA analog. It was originally developed for the treatment of epilepsy, and currently is also used to relieve neuropathic pain. There are, however, concerns regarding the quality of the trials conducted for a number of conditions.[1]

Web Site: http://www.depomed.com

  1. Vedula, SS; Bero L; Scherer RW; Dickersin K (November 2009). “Outcome reporting in industry-sponsored trials of gabapentin for off-label use”. The New England Journal of Medicine 361 (20): 1963–71. doi:10.1056/NEJMsa0906126. PMID 19907043.
  2. “Gabapentin”. The American Society of Health-System Pharmacists. http://www.drugs.com/monograph/gabapentin.html. Retrieved 3 April 2011.
  3. Vedula, SS; Bero L; Scherer RW; Dickersin K (November 2009). “Outcome reporting in industry-sponsored trials of gabapentin for off-label use”. The New England Journal of Medicine 361 (20): 1963–71. doi:10.1056/NEJMsa0906126. PMID 19907043.
  4. Moore, RA; Wiffen PJ; Derry S; McQuay HJ (2011-03-16). Moore, R Andrew. ed. “Gabapentin for chronic neuropathic pain and fibromyalgia in adults”. Cochrane database of systematic reviews (Online) (3): CD007938. doi:10.1002/14651858.CD007938.pub2. PMID 21412914.
  5. Ho, KY; Gan TJ; Habib AS (2006-12-15). “Gabapentin and postoperative pain–a systematic review of randomized controlled trials”. Pain 126 (1–3): 91–101. doi:10.1016/j.pain.2006.06.018. PMID 16846695.

 

File:Gabapentin 3D.png

 


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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