Insys Therapeutics, Inc is a pharmaceutical company based in Chandler, Arizona. The company was founded in 1990 by Dr. John Kapoor. Dr. Kapoor was born in India and attended the University of Mumbai, obtaining a pharmacy degree. He came to the United States on an academic scholarship, and in 1971, he received a doctorate in medicinal chemistry. He remains the executive chairman of the company and had to take over a more active leadership role after a number of scandals. Dr. Kapoor has risen from humble beginnings to become a billionaire as a result of his formulation of Insys Therapeutics, Inc.
Medications Marketed by Insys Therapeutics
Insys Therapeutics is a specialty pharmaceutical company that has specialized in a few products that can be delivered as oral sprays. The current products marketed by Insys Therapeutics are outlined below.
- Subsys is a sublingual fentanyl spray. Fentanyl is a powerful opiate drug used in the treatment of severe pain and as an anesthetic. It is extremely potent, fast-acting, and remains in the body for a short duration. The drug has also received publicity due to it being laced with heroin and resulting in a number of fatalities in individuals who use heroin. Fentanyl is a Schedule II controlled substance as classified by the United States Drug Enforcement Administration (DEA). The sublingual spray allows for more efficient administration of the drug.
- Syndros (dronabinol) is an oral formulation that is a synthetic version of the active ingredient in cannabis, delta-9-tetrahydrocannabinol (THC). The FDA has approved its use for the treatment of individuals who have anorexia, for weight loss in individuals diagnosed with AIDS, and for individuals who have gastrointestinal issues, such as nausea and vomiting as a result of chemotherapy. Syndros still needs to be scheduled by the DEA as a controlled substance. THC remains a Schedule I controlled substance, indicating that it has no approved medicinal uses and cannot be obtained except under very special permissions by the federal government (mostly for use in research).
Insys Therapeutics also lists a number of medications that are currently in clinical trials. These include:
- Buprenorphine sublingual spray: Buprenorphine is an opiate medication that is a partial opioid agonist. It is often used as an opioid replacement medication to assist individuals who are withdrawing from opioid drugs (e.g., by itself or in the medication Suboxone, which combines buprenorphine and naloxone) and can be used in the treatment of pain like nearly all of the opioid medications. The formulation being tested for Insys is an oral formulation being evaluated for its effectiveness as a pain reliever. It is currently in Phase III clinical trials.
- A naloxone sublingual spray: Naloxone is an opioid antagonist drug that is used in the treatment of individuals who have overdosed on opiate drugs. If administered early enough, it can be a lifesaving drug. This version is an oral spray version of the drug that would have a quicker onset of action and be easier to administer by nonmedical personnel. It is currently in Phase III clinical trials.
- Cannabidol: Cannabidol is an application of the active ingredients of cannabis products (THC) for the treatment of epilepsy in pediatric patients. It is currently in Phase II clinical trials.
- A buprenorphine/naloxone sublingual spray: This formulation would be equivalent to a liquid oral application similar to Suboxone that can be used to treat withdrawal symptoms in individuals recovering from opioid dependence. The formulation is currently in Phase II clinical trials.
- An ondansetron sublingual spray: Ondansetron is a serotonin antagonist drug that is currently used in the treatment of nausea and vomiting, particularly for patients who are undergoing chemotherapy. The spray would make it easier to administer. This formulation is currently in Phase II clinical trials.
- Liposome Entrapped Paclitaxel Easy-To-Use (LEP-ETU): LEP-ETU is a formulation designed to treat ovarian cancer. It is currently in Phase II clinical trials.
Drugs in Phase III trials are closer to being approved than those in Phase II trials. In Phase III trials, larger groups of individuals are used to study the effects of the drug, and the side effects are monitored very closely prior to marketing. Drugs in Phase II clinical trials are at the mid-stage of the research process leading to formal approval. There are four phases in clinical trials, with the fourth phase occurring while the drug is being marketed to actual patients in practice. Phases I-III of clinical trials occur exclusively in clinical research settings with research participants.
Scandals and Lawsuits
Insys Therapeutics has been involved in a number of lawsuits and scandals in its short history. The most recent issue involved managers and executives of the company who were arrested as a result of an investigation by federal prosecutors in Massachusetts. The case alleges that employees of the company, including the former president and CEO, engaged in a conspiracy to bribe medical personnel in several states to increase prescriptions written for Subsys. The allegations are quite severe and indicate that prescriptions were written to patients who did not have cancer, even though the medication is to be prescribed only to individuals who are suffering from cancer pain. According to the allegations, the physicians were paid on a sliding scale based on the rate of prescriptions they had written while engaging in public speaking and educational speaking appearances, an obviously illegal practice.
Insys is also alleged in the allegations to be a significant supplier of Subsys to businesses that are known to illegally prescribe opiate medications in large quantities to individuals who abuse the medications; therefore, this practice contributes to the prescription opioid abuse epidemic in the United States. One report describes the situation to be one of the worst violations of this nature ever witnessed.
According to another article, the CDC released a report on the day of the arrests that indicated that overdose deaths as a result of abuse of synthetic opioids like fentanyl increased nearly 75 percent in the year prior to the arrests at Insys. Opioid-related deaths in the United States surpassed gun homicides in 2015, according to these reports.
Insys Therapeutics, Inc. is a company that currently markets an oral form of the dangerous narcotic drug fentanyl, and it has several other drugs that are currently at different stages of development. Insys has been accused of some serious ethical violations and illegal marketing practices. Given that it specializes in easy-to-administer drugs that are potentially addictive, the company is closely monitored by governmental agencies.
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