Pharmaceutical companies in the U.S. may now move forward with their pursuit of formulating a drug that may treat or prevent cold sores after the Food and Drug Administration (FDA) recently completed its guidelines for developing antiviral drugs.
Clinilabs.com recognizes the fact that Americans who suffer from cold sores or recurrent herpes labialis (RHL) comprise up to 40% of the adult population. The FDA said that the finalized rules bear several similarities to the draft version that was launched in July 2016.
The initial version requires drug makers to have a “toxicity grading scheme” for clinical tests, which was then excluded the finalized guidance. The toxicity adverse event grading scale would have prompted sponsors to treat “toxicities with a relatively low grade assignment” may have been less desirable in healthy participants of RHL clinical tests, as opposed to those who participate in clinical studies of drugs for cancer or the HIV.
The FDA’s finalized standards reflect its expectations on a number of medical efforts, including safety studies for Phase 1 drug trials. It also includes guidelines for conducting Phase 2 and Phase 3 trials.
According to the FDA, clinical research phase studies comprise four stages. The first involves between 20 and 100 healthy participants with the target disease or condition of the drug. This phase may last for several months. An estimated 70% of drugs move to the next stage.
The second phase aims to determine the efficiency and side effects of the drug. A study of up to several hundred people with the disease may take up to two years, while around 33% of drugs move the third stage. This phase typically last up to four years with a sample size of up to 3,000 volunteers. Around 25% to 30% of drugs move the fourth phase, which aims to study the drug’s safety and efficiency.
The FDA’s finalized guidance for RHL represents a step in the right direction to find a cure for cold sores. Does this mean consumers or patients can expect more from pharmaceutical companies?