Curr Opin Invest Dr
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Gabapentin has been approved for the treatment of neuropathic pain in six European countries, New Zealand and Australia, and numerous countries in Latin America. By January 2001, Pfizer was preparing to file an NDA in the US for this indication; by October 2001, this NDA had been filed with the FDA. The drug is a GABA analog, but is not a GABA mimetic, although some neurons that respond to gabapentin are GABAergic. ⋯ Gabapentin is also a substrate for the large neutral amino acid transporter, and this may be the major route allowing gabapentin access to the CNS. Modulation of synaptic transmission between primary afferents and substantia gelatinosa neurons, and blockade of signal transduction, are two potential mechanisms of action, in addition to inhibition of glutamate release by voltage-sensitive calcium channels. In September 2001, Morgan Stanley predicted sales of US $1871 million in 2002 falling to US $413 million in 2006.
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Endo (which acquired Algos in July 2000) has developed EN-3231, a combination of morphine and dextromethorphan, for the treatment of moderate-to-severe chronic pain. In October 1998, the FDA accepted for filing the company's NDA submission on EN-3231, which was submitted in August 1998. ⋯ The FDA requested a second pivotal trial, which Endo initiated promptly. Endo hoped to file its supplement to the NDA during 2002.
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Pharmacia (formerly Searle), in collaboration with Pfizer and Yamanouchi, has developed valdecoxib, a second-generation cyclooxygenase (COX)-2 inhibitor as a follow-up to celecoxib, for the treatment of arthritis. Pharmacia filed an NDA with the FDA in March 2001 for the treatment of acute pain, dysmenorrhea, osteoarthritis (OA) and rheumatoid arthritis (RA). At this time, Pharmacia anticipated a 12-month review [402883]. ⋯ Credit Suisse predicted in this month that total sales would reach US $330 million in 2002, rising to US $1832 million in 2004 [422318]. In September 2001, Morgan Stanley expected launch in the first half of 2002 [427113]. By October 2001, Credit Suisse had revised its sales predictions to US $180 million in 2002, US $790 million in 2003 and US $1,430 in 2004 [427185].
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Citicoline was originally developed and launched by Ferrer for the treatment of stroke, and is now also being investigated for the potential treatment of Alzheimer's disease (AD). In the US, the compound is being developed by Interneuron for the treatment of stroke. A US launch had been rescheduled for 2002 although a decision on future US development of citicoline was intended to be made in conjunction with Takeda, Interneuron's US licensee. ⋯ In 1993, Interneuron licensed exclusive marketing and manufacturing rights to citicoline in the US and Canada from Ferrer. By September 1997, a patent application had been filed worldwide by Interneuron for the use of citicoline in the reduction of cerebral infarct volume, and in September 1998, US-05801160 was issued for citicoline relating to the protection of brain tissue from cerebral infarction following ischemic stroke. In December 1999, US rights to the commercialization of citicoline were licensed to Takeda.