Development of Drug and its Clinical Trial

As competition in the pharmaceutical industry gets intense, pharmaceutical companies are racing for innovating new products/medicine that would change people’s life. Two issues become key attractions in the business. First, the industry is characterized with large number of inventions, which further become the basis of competition in the industry. Second, the industry also continues exhibiting new marketing strategy in order to differentiate them from their rivals/competitors. Sometimes, a similar ingredient of a medicine is commercially campaigned in television and other media to have stringer and better impact to cure particular disease.

            This paper would not specifically discuss about how to market a drug. It fact, it will focus on the discussion of a drug that is successfully released into the market after officially passing the clinical trial. The chosen product is GlaxoSmithKline’s Ventolin inhaler, which is produced for relieving an asthma attack including its clinical trial.

The Development of Asthma Treatment

There are three facts that everyone should know regarding asthma. First, asthma is a chronic disease, which means a patient faces it every day. The important thing is the patient should avoid particular triggers that would lead to asthma attack, which may be caused by several things that are specific to each patient. Some consider dust and animals’ furs are the trigger, others find that some foods are the triggers, and the rest consider heavy exercise as the causes. Second, asthma is not a light disease since in many cases it is considered life threatening. Third, there is no exact cure for patients with asthma. They had better manage their life to carry out a normal and healthy life to reduce and prevent any chance of asthma attack.

According to a research in 2002, about 75 million American people live with asthma and other allergic diseases. At least 5,000 of 75 million end in deathly attack. This considers as a serious disease that requires special attention as the number of children that experience asthma continue increasing nowadays. Several drugs have been produced and special treatments have been developed and found to cure people with asthma. However, a data shows that the number of patients have increased by 80 percent over all ages and ethnic groups.

Latest Development and Research

Asthma and Prescription Drugs

            The development of drug to relieve asthma attack is managed carefully. This is because asthma is a severed disease and the drug can only be purchased by physician’s prescription. Ventolin Inhaler, for example, is a product that uses the inhaler method and considered as prescription medicines. In its official website......, GlaxoSmithKline, the Ventolin producer, writes in bold that “this medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.” The aim of this warning is not to give this inhaler product to children under 4 years without adult supervision as prescribed by the patient’s doctor.

            Since wrong medication can be deadly, therefore, only doctor can prescribe medicine. However, the wrong medication can be caused by wrong actions by pharmacists. This is true since the problem of pharmacy errors get worse these days since the number of prescriptions rise. This situation greatly put pharmacists under pressure to work as fast as they can.

Under such circumstances, some states in the U.S. issue law that rule the use of prescription medicine. In conclusion, while medicines can be bought by a doctor’s prescription, consumer should beware of pharmacists and take necessary action when dealing with them. 

Clinical Tests on Animals, Cell Cultures and Humans

            Concerning the importance of asthma treatment, many researchers have established clinical tests to develop the drug efficacy and ensure the safety. It also discusses why physicians strictly recommend prescription drugs for asthma patients. The specific drug that will be discussed is inhaler, a special medication for asthma, which provides a quick relieve for those who experience an attack.

            Like other product development, Ventolin inhaler also passes some clinical test before commercially launched into market. There are several steps in the drug discovery processes as shown in the Figure 1 that describes the drug development and production. The first process is the medical needs identification. This includes the efficacy analysis on existing medication and therapy. The analysis is then followed up by the evaluation of current information about the target disease, which results in new hypotheses on how to improve the therapy. In this step, the efficacy of each therapy is identified and is further advanced to treat patients with target disease.

Following the hypothesis then the project continues with the set of research objectives and proceeds the testing on animals. During animal test, several important steps include monitoring biological activity in animal, obtaining a related compound and optimizing the process in the preparation of similar structures, and at the end choosing one compound as the drug candidate.

Once the drug candidate is selected, it further undertakes the toxicological testing in animals as mandatory according to law. If the chosen compound passes all tests, prior to clinical trials, the historical research data is submitted to the Food and Drug Administration (FDA) as an Investigational New Drug Application (IND). FDA is a government agency in the United States while other countries also have similar agencies with different name.

Statistically, very few drug (4-7%) candidates pass these entire tests. A team of experts at FDA then conducts a completed test on the successful new drug application (NDA), which is accompanied with completed research data. Only drug that has been rewarded the approval from FDA can be offered to physicians for prescription.

Clinical Tests of Ventolin Inhaler

            The reason of Ventolin Inhaler to be considered as prescription medicine is that it contains active component of VENTOLIN HFA is albuterol sulfate, which is similar to salbutamol according to The World Health Organization (see Figure 2) and other components. 

In order to prevent any adverse impact on human, the clinical tests are carried out at a given period. The clinical test for Ventolin is performed in a 12-week double-blind trial by comparing the effect of Ventolin HFA to CFC 11/12-propelled albuterol and an HFA-134a placebo inhaler. The clinical trial involves adults at 12-76 years of age that experience varied asthma attack from mild to moderate level.

The measurements of serial forced expiratory volume in one second indicate that the respondents that take two doses (two inhalations) of Ventolin HFA experience significant improvement compared to placebo. The trial measurements also obtain important findings that people that exercise should take two inhalations of Ventolin HFA about 30 minutes in advance.

Another clinical test on Ventolin Inhaler is carried out in different occasion. The test includes 248 patients that take Ventolin HFA within 2 to 12 week-test period. The measurement shows varying results. For pediatric patients, it is found that patients at 4 to 11 years of age experience undesirable reaction like their adults counterpart (See table 1).

Conclusion

Asthma is a chronic disease that requires a serious treatment as it attacks not only adults but also children and for some cases, it causes death. According to American Lung Association, patients with Asthma have difficulty to move air in and out of their lungs.

            This paper has elaborated the medicine for asthma. The chosen product is GlaxoSmithKline’s Ventolin inhaler, which is well-known for relieving an asthma attack. As asthma treatment is continuously improved, this paper will also include the latest development and research and the test on animals or human that the drug has undergone.