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Naltrexone pharmaceutical company

Posted Apr 22, 2016 by Admin

 Some patients feared naltrexone would make them more vulnerable to these cravings, and felt that methadone was more effective in controlling them. Because of these recruiting difficulties, researchers made no effort to screen out patients who might be difficult to manage in clinical trials.The final results of the clinical trials showed that naltrexone was modestly successful in the reduction of heroin use. In 1984, the FDA approved naltrexone in a 50mg dose as a treatment for heroin addiction.  Most facilities could not afford to implement naltrexone therapy due to the combined price of the drug, the drug treatment program, and the additional time and staff necessary for psychosocial counseling.

"We did it without any outside funding says O'Brien. "We got it started against pretty great odds." According to O'Brien, the researchers had difficulty recruiting subjects because the idea of treating alcoholism with medication was not commonly accepted in the 1980s.In 1985, Volpicelli and Dr. Charles O'Brien, a professor at Penn and chief of psychiatry at Philadelphia's Veterans Administration Center, began a naltrexone study using volunteers at the Veterans Administration Hospital.

After the Penn and Yale studies were published in the Archives of General Psychiatry in November 1992, DuPont showed interest in marketing naltrexone specifically as an alcoholism treatment. Governmental funding for the development of naltrexone as a therapy for alcoholism was provided by the National.By mid-1974, as SAODAP began to phase out of existence, the narcotic antagonist development project fell to the newly formed National Institute on Drug Abuse (NIDA ). That same year, NIDA approached DuPont with the idea of developing naltrexone as a drug addiction therapy, and.

At the time it seemed unlikely that DuPont would develop naltrexone, because at the time, naltrexone seemed to have relatively low market potential, and its patent would probably expire before the completion of any clinical trials. The subsequent human trials confirmed that the drug was safe for humans, but the efficacy trials ran into some unexpected problems. Dr. Arnold Schecter, who conducted many of the early studies, reported that many opiate-addicted patients feared a new drug, lacked a desire to become.

 One former member of the DuPont sales force said these misunderstandings were a great barrier to the use of Trexan. DuPont also had an extremely difficult time trying to convince methadone clinic personnel to use Trexan.Naltrexone, short for Naltrexone Hydrochloride (C20H23NO4-HCl is an opiate antagonist.  At a therapeutic dose of 50mg per day, Naltrexone blocks the parts of the brain that feel pleasure when a person uses alcohol or narcotics.

Naltrexone safe

 Dupont brand-named the drug Trexan. The same year, DuPonts naltrexone patent expired. On March 11, 1985, the FDA designated naltrexone as an orphan drug, which provided seven additional years of market exclusivity for naltrexone for DuPont.The Federal Government Steps In In June 1971, President Nixon created the Special Action Office for Drug Abuse. Prevention (SAODAP ).  The first director of SAODAP, Dr. Jerome Taffe, was determined to improve access to drug abuse treatment by shifting services from prisons and hospitals.

As a result of these problems, Trexan failed to penetrate the highly regulated federal treatment market for opioid addiction. By 1995, Trexan sales were approximately 5-8 million annually, which represented approximately 15-25,000 patients per year, or less than 5 of the estimated number of heroin.Naltexone as a Treatment for Alcoholism Dr. Joseph Volpicelli first recognized naltrexone's potential to treat alcoholism while experimenting with rats as a graduate student in University of Pennsylvania.  In 1981, he began to publish his findings.

 When these areas of the brain are blocked, a person feels less need for one more drink or one more hit. FDA-approved for the treatment of alcohol and opiate abuse, Naltrexone has recently shown great promise in the treatment of other medical conditions. I regarded the development of naltrexone as one of my high priorities, said Dr. Taffe. SAODAP recognized that the development of naltrexone was of no burning interest to the private pharmaceutical industry, and that governmental funding would be necessary to bring it to market.

Marketing exclusivity allows a pharmaceutical company to sell its drug for a certain length of time free of competition from generic versions of the drug. This type of marketing exclusivity is often granted to encourage pharmaceutical companies to develop a use for a drug whose.Since naltrexone is non-addictive and lacks the reinforcing effect of methadone, it requires more extensive psychosocial support services than methadone. Support services are expensive.  Schecter estimated that total clinical treatment with naltrexone was almost twice as expensive as methadone  - not because of the medication.

Marketing Strategy for Trexan The DuPont sales force had trouble explaining the mechanism of naltrexone and its benefits to a lay audience. The consumer marketplace had many misunderstandings and negative perceptions about naltrexone.The FDA modified existing regulatory requirements to encourage DuPont to develop naltrexone as an alcoholism therapy.  They offered DuPont three additional years of post-approval market exclusivity for naltrexone as an alcohol therapy.

As a result of these findings, the product labeling for naltrexone reads, "Naltrexone does not reinforce medication compliance and is expected to have a therapeutic effect only when given under external conditions that support continued use of the medication". Many addicts were unable to comply, due to the physiological effects of withdrawal. Taking naltrexone does not provide any drug reinforcement (high and produces no negative consequences (withdrawal) when discontinued.  Unlike methadone, which helps suppress cravings, naltrexone has no effect until the addict attempts to.

In 1991, researchers at Yale University School of Medicine tested the effects of naltrexone in conjunction with psychological therapy in 104 alcohol-dependent men and women.  Patients who took naltrexone were nearly twice as successful in their clinical outcomes as those who took a placebo.They tracked 70 men for 12 weeks in an outpatient detox program. Half received naltrexone, half a placebo.  While 54 of the volunteers who received a placebo reverted to drinking, only 23 of those who took naltrexone experienced a relapse.

Patients had to remain opiate-free for a minimum of 5 to 10 days prior to treatment because naltrexone causes severe withdrawal symptoms in patients with opioids in their system (Schecter 1974).Early trial results showed that, compared with the methadone patients, the patients who were attracted to naltrexone therapy were relatively "more motivated and emotionally stable."  Other studies showed that although naltrexone was an effective opiate block, clinical success (a reduction in heroin use was limited.