When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND and parallel tracking also occur at this stage or phase. Upon completion of phase III, the manufacturer files a New Drug Application or NDA, which is reviewed for 1-2 years. At this stage, the FDA consults advisory committees of experts for advice on safety, effectiveness and labeling. If and when approved, marketing may be done with FDA-regulated labeling. FDA also collects safety information on the drug's use and adverse effects, if any. There will be occasional requests for changes in labeling or news releases of any eventual contraindications. Should there be systematic or serious adverse effects, FDA may withdraw the product from the market. FDA has tended to expand and increase its regulations and requirements. An example was a typical drug, which underwent 30 clinical trials of 1,500 patients. In 1990s, it had to undergo 60 additioal clinical trials of almost 5,000 patients (FDA).
High Public Acceptance
A single-center, randomized, double-blind and placebo-controlled trial was recently conducted on 34 OAB male and female patients at the Guy's Hospital in London, UK from May 2004 to February 2006 (Sahai et al., 2009 p 1509). The objective was to determine if botox treatment affects the quality of life of patients with the condition, refractory to anti-cholinergics. They received 200 units of botox and their quality of life was assessed through the King's Health Questionnaire at 4 and 12 weeks after botox injection. Results showed that the majority of patients experienced improved quality of life. Their symptoms also improved in the overall at 4 weeks. It concluded that botox A bladder injections at 200 units seem to improve the quality of life and OAB symptoms of the respondents for at least 24 weeks (Sahai et al. pp 1510-15).
A MEDLINE and EMBASE evaluation of 18 clinical studies on treatment with botox intradetrusor injections on adults with neurogenic detrusor over activity or OAB and urinary continence of OAB symptoms found that it was effective (Karsenty et al., 2007). In most of the cases, 300 units of botox were injected in the bladder under cystoscopic guidance and anaesthesia. Improvement was recorded in 40-80% of the patients who became completely dry, urodynamic pressure reduced and quality of life improved. The review concluded that botox injections provide significant improvement on patients with these disorders resistant to anti-muscarinics. Botox is also quite tolerated. However, it still needs better designed controlled trials and answers to questions on optimal dose, longest duration of efficacy, timing and indications of repeat injections and patients who will best benefit from it (Karsenty et al.).
A five-minute telephone survey of 72 botox patients revealed that 67% of them were satisfied with it and considered continuing with the treatment (Hori et al., 2009). The survey was intended to evaluate their perspective on BTX -- A as a long-term treatment for their neurogenic detrusor over-activity, secondary to spinal cord injury condition. Only 7 or 15%, still undergoing botox treatment, would consider alternative permanent surgical options in the succeeding 5 years. Those considering botox on a permanent basis were younger. New recruitment rate was high at a 14.4 mean and annual withdrawal rate was low at 4.8. Because of the high satisfaction and demand rate, there is need to optimize the current delivery of intradetrusor botox injections for NDO patients (Hori et al.).
Key Players
Market research reports that there are 19 companies, which are the key players in the Botox market worldwide (Global Industry Analysts, 2009). These companies include
Allergan, Inc. USA; Ipsen Group France; Lanzhou Institute of Biological Products China; Metabiologics, Inc.USA; Merz Pharmaceuticals GmbH Germany; Mentor Corporation USA, Medy-Tox Incorporated South Korea, Medicis Pharmaceutical Corporation USA, and Solstice Neurosciences, Inc. USA (Global Industry Analysts).
Observers say that U.S. FDA approval of Botox is likely and coming (Benesh, 2010). This will be the first major medical application for Allergan and boost its fortune. The benefits of Botox are temporary and its increasing stream of patients will continue keep coming back. That insures Allergan's prosperous stand. Most of these patients are women who want their wrinkles and crow's feet erased. They are sure clients every three months. And its cost is not open to insurer pressure because insurance companies do not cover it. Allergan made $1.3 billion in sales from Botox in 2009, 30% of its total revenue for the year. With its forthcoming use for migraine headaches, Allergan could make an additional $1 billion a year from it.Its CEO, David Pyott, said Botox holds 79% of the global aesthetic market and still growing at 13% every year. Its long-term development program...
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