This page was created as part of a class assignment at Davidson College. It is intended as an informational view of the process of prescription drug development and approval. "Wildcat Elixir" and "Dana Bioceuticals" are fictional entities created for this purpose.

 

 

Research and Development are the critical phases in the life of any drug or other consumer good. It is in these stages that the product is designed and directed for a specific purpose. The buttons at the left take you through the different aspects of drug research that we have dealt with in the context of Wildcat Elixir, and that all pharmaceutical companies deal with when developing their own drugs.

Other Treatments for Erectile Dysfunction

First Line Treatments

Hormone replacement:
Treatment with hormone therapy has been shown to be effective. With this method, patients are either periodically injected with androgens, or they ingest them orally. However, possible complications include the suppression of natural hormone production, and prostate cancer.
Psychosocial Counseling:
Though ED is usually rooted in vascular and hormonal causes, the psychosocial implications of the disease cannot be disregarded. Therapy is an important factor in any treatment plan.
Vacuum Pump:
The vacuum pump is effective in most ED cases. It is non-invasive, approved by the FDA, and can be purchased over-the-counter. Side effects include penile pain, bruising, numbness, and delayed ejaculation (Levine, 2000).
Acupuncture:
This relatively new method has been very successful, though few studies have been performed to evaluate its effectiveness (Crimmel, 2001).

Second Line Treatments

Self-Injection:
This requires the patient to inject a vasoactive drug directly into the penis. Though effective, its side-effects are more prevalent. They include prolonged erection, penile pain, penile fibrosis, and hematoma.
Penile Prostheses:
Probably the most invasive of today's treatments, penile prostheses are only used as a last resort, and should only be performed if all other treatments have failed.
Vascular Surgery:
This procedure is still in its experimental stages; it involves repair of venous damage in the penis.

Under FDA Review:

Apomorphine:
Taken sublingually, apomorphine acts as a dopamine receptor agonist (Levine, 2000).

Side Effects

Positive:
- Increased duration and rigidity of erection
- Increased response to visual stimulation
- Aids in producing viable spermatozoa on demand
- Effective in individuals who are undergoing radiation or drug therapy or those who are suffering from diabetes and many neurological disorders.

Negative:
- Headache
- Stomach upset
- Cannot be administered to individuals suffering from cardiovascular disease due to its abilities as a vasodilator and due to the risk of heart attack due to over-exertion.
- Dizziness
- Flushing
- Blurred vision
- Anal leakage


How Wildcat Elixir Works In Your Body

Wildcat Elixir (dimethylhexylimpropylcycloxenathon) acts a phosphodiesterase inhibitor in a Nitric Oxide mediated cellular cascade that eventually ends in erection. It appears as though men suffering from erectile dysfunction have increased levels of phosphodiesterase, preventing erection from occurring. Phosphodiesterase is an enzyme that breaks down the cyclic nucleotide, cGMP. When this enzyme is inhibited, the cellular cascade may occur with no interference until erection is achieved.

Figure Information

When an individual suffering from erectile dysfunction begins treatment with Wildcat Elixir, the normal cellular pathway that leads to erection is restored. The compound binds with the phosphodiesterase molecules within the cell, thus preventing the destruction of cGMP molecules. The normal pathway begins when Nitric Oxide enters the cell through a transmembrane protein and is transported by way of intermediary complexes to cGMP where it binds. Once binding has occurred, cGMP magnifies the signal and sends it by way of molecular carriers to the protein kinases located in the cytosol. The kinases then cause an increase in the translation of the erecterin-2 gene within the nucleus, which then facilitates the contraction of smooth muscle tissue and the eventual erection.


Development of Wildcat Elixir

While monitoring dimethylhexylimpropylcycloxenathon's possible hypotensive effects on live rabbits, our researchers observed that the compound was causing smooth muscle contraction on the lupine corpus cavernosum tissue resulting in erection. As a result, our researchers redirected their efforts from developing a drug to treat hypertension to the development of a drug to combat erectile dysfunction (ED).

Research began at the in vitro level. Dana Bioceuticals' research team added varying dosages to rat, rabbit, and eventually human corpus cavernosum tissue and studied the compound's effect on smooth muscle contraction. Contraction was again noted in all three types of tissue samples and dosages were refined in these initial studies.

After the initial in vitro studies, research moved on to live animal investigations using rats, rabbits, and lambs as test subjects. Animals were subjected to varying doses of what was to become Wildcat Elixir in order to illuminate any possible side effects, either positive or negative, that arise from the prolonged use of the drug. Through close monitoring of the drug's effects on the cardiovascular system of the test subjects, it was discovered that dimethylhexylimpropylcycloxenathon was a reasonably potent vasodilator. The compound induced the opening of Na+/K+ channels in blood vessels responsible for vasodilation.

After a prolonged review of the results of the in vitro and animal studies by the FDA, the research team was given the go ahead to conduct clinical trials on humans. Many different types of studies, including comparison investigations, double blind tests, and others were conducted. But one example of one of the most important types of epidemiological tests conducted is the initial placebo test. The placebo study was conducted on 86 males between the ages of 45 and 60 over a three-month period. All the men suffered from documented cases of erectile dysfunction but were otherwise healthy. Half the men were given 40 mg of dimethylhexylimpropylcycloxenathon once a day and half were given a 40 mg sugar placebo once a day. 35 individuals out of 43 taking the actually drug (86%) experienced a marked improvement in their ability to achieve and maintain an erection. 10 individuals out of the 43 individuals on the placebo treatment experienced a noticeable improvement in their condition. Again, many other tests were conducted over a period of years to study and refine all aspects of the drug and the side effects it might be responsible for causing.


 

© Copyright 2001 Department of Biology, Davidson College, Davidson, NC 28036. Send comments, questions, and suggestions to: kabernd@davidson.edu