New Drug Development

Drug PrescriptionResearchers are unraveling the mysteries behind the genetic makeup responsible for many diseases. The identification of certain genes and their molecular activities has allowed scientists to zero-in on how disease develops. In turn, this knowledge has led to the formulation of new drugs capable of controlling symptoms or hopefully, even eradicating disease.

As the population ages, new medications are needed to treat disease and increase the quality of life. Many pharmaceutical companies are addressing this need by contributing more research dollars to the development of drugs for seniors. Merck Pharmaceuticals is an example of a company whose drug, Fosamax has benefited many people who suffer from osteoporosis.

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Osteoporosis is a serious disease that decreases bone density. It has been responsible for more than 250,000 hip fractures annually. The associated medical cost to treat these fractures is in the neighborhood of $13 billion! This disease can also cause spinal compression fractures (and vertebral collapse), which is extremely painful and debilitating.

Medicare conducted a study of their beneficiaries from 1982 to 1994. It found the disability rate among seniors dropped 1.3 percent per year during that 13 year period. That decrease can be attributed to many of the new drugs that entered the market, some of which are used to treat osteoporosis and arthritis.

This is all good news, but new drugs are not cheap. A pharmaceutical company may spend 10 or more years and $400 million in the development phase. It should also be noted that not every drug is approved for use. The Food and Drug Administration (FDA) is one of strictest regulatory agencies in the world.

For example, before human clinical studies are performed, the drug must meet FDA requirements for pre-clinical studies. This means that all data from laboratory or animal studies must prove the compound safe. This includes evaluating the drug's toxicity and pharmacologic effects in vitro (biologic reactions in laboratory apparatus) and in vivo (in a living organism). The sponsor (drug manufacturer) must develop an in-depth pharmacological drug profile against the disease.

After pre-clinical testing is documented and completed, the sponsor files a document called an IND (Investigational Drug Application) with the FDA. If approved, this allows the sponsor to move ahead to the next stage of drug development known as human clinical trials.

Prior to the commencement of human clinical trials, the FDA requires the formation of an Institutional Review Board (IRB). This is a group of at least 5 experts and lay people with different backgrounds who are professionally competent. Their responsibility is to review the sponsor's research protocols, informed consent documents, investigator brochures, and other documents related to the trial. The FDA monitors IRBs to ensure the safety of trial participants. All trial volunteers must be provided with sufficient information about the trial/drug in order to make an "informed consent" - prior to trial participation.

Human clinical trials proceed through several phases. The first phase (Phase I) may involve as many as 100 volunteers who are normal and healthy. The results from Phase I trials determine drug absorption, how it is metabolized, and excreted from the body. This phase also tests the drug's safety.

The next step is Phase II, where volunteers with the disease for which the drug is intended are used. This phase may involve hundreds of volunteers and is very controlled. Phase III trials often involve patients who are in a clinical or hospital setting. Each patient is closely monitored to determine if any adverse reactions occur. Sometimes the FDA requires the sponsor to conduct a Phase IV trial.

As stated, during each phase, every volunteer is closely monitored. This may involve taking and recording their blood pressure, pulse, and weight during regularly scheduled visits. Depending upon the trial protocol, certain laboratory tests may be run such as blood and urine.

When the human clinical trials are completed, the sponsor analyzes the data collected and files a New Drug Application (NDA) with the FDA. This report demonstrates in writing the drug's safety and effectiveness scientifically. It may take the FDA up to a year to review and approve a new drug.

Once approved by the FDA, the drug is made available to physicians for patient use. However, the pharmaceutical company's responsibility for this new drug does not stop once it reaches the market. The company must continue to report any adverse reactions or quality issues to the FDA.

Despite everything involved in new drug development, pharmaceutical manufacturers continue their quest for new drugs. There are so many new drugs in the pipeline now that the future looks bright for the treatment of spinal disease today and tomorrow.

Updated on: 05/24/16
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