Why the FDA Approval Process Is Under Scrutiny Following Approval of ‘Numbrino’, a Cocaine-Based Nasal Spray

Published on February 22, 2020

Pharmaceutical corporation Lannett Company, Inc. announced that the Food and Drug Administration (FDA) approved its New Drug Application, Numbrino, the brand-name for a cocaine hydrochloride nasal spray commonly used to treat Nasal Anesthesia. Not available for in-store retail, Numbrino will be made available to otolaryngologists as an anesthetic during nasal operations. 

An otolaryngologist, for the uninitiated, is a doctor who is specialized to treat and manage diseases and disorders of the ear, nose, throat, and related bodily structures such as the head and neck.

As a result, business is of course booming for Lannett, as it recently saw an increase of company shares at 5.7%. Its CEO, Tim Crew described the recent approval by the FDA as a “major milestone in Lannett’s 70-plus years of operations.”

But, the FDA’s recent practices have been seriously called into question following this approval for one reason: the safety of the spray itself.

Uhhh FDA…Are You High? The Spray Is Cocaine, After All.

Cocaine is a Class A illegal drug which yields a maximum prison sentence of up to seven years, if an individual is caught possessing it. However, if used in low dosages, such as in the field of dentistry, it can be used as an anesthetic, according to WebMD.

Yet, its use in the medical field has begun to decrease primarily because of other alternatives such as benzocaine, proparacaine, lodicaine, and tetracaine.

What the Hell Was the FDA Thinking Here?

According to NPR, FDA’s quick approvals are mainly due to weak evidence, and experts have quickly made their opinions known.

“There has been a gradual erosion of the evidence that’s required for FDA approval,” said attorney Jonathan Darrow, of Harvard Medical School’s Program on Regulation, Therapeutics and Law. “As a result, patients and physicians “should not expect that new drugs will be dramatically better than older ones.”

From a consumer perspective, there’s no certainty in the efficacy on these newer legal drugs. In the case of Numbrino, the FDA approved it only after going through Phases One and Three clinical trials.

Almost half of the recent new drug approvals were based only on one pivotal clinical trial, instead of the two or more that used to be the norm, according to Darrow’s published study on this in JAMA, the journal of the American Medical Association.

Researchers found that the average number of new drug approvals per year increased from 34 in the 1990s to 41 in the 2010s, after a dip to 25 a year in 2000s.

What the study shows is that the FDA is processing these approval applications much faster than they used to, which apparently has been the goal of many legislative and regulatory changes starting in the 1980s since Congress’ passage of the Orphan Drug Act. The average time for approval by the FDA was one year and a half, from 1993 to 2005.

From 2006 to 2017, the time fell to a year and two months. But in 2018, it fell to just eight months. These changes are happening due to the fact that the pharmaceutical industry pays the FDA “User Fees” to accelerate the process needed for approval. 

But Why? Money Is One Hell Of A Motivator

Darrow has recently discovered that the annual fees the FDA has received from Big Pharma has increased from $29 million (1993) to $908 million (2018).

He stated that “if the majority of funding of FDA personnel comes from industry, the FDA will begin to consider industry as its primary client rather than the public.”

The public already knows of the role the pharmaceutical industry played during the opioid crisis.

Are we ready to have another one with cocaine?

The answer isn’t an easy one, especially when the use of hardcore drugs are being used more frequently than before.

Tripping With Drugs

Psychedelic drugs are being used more frequently in clinical trials to ensure their safe debut into the mainstream health system.

According to Fortune, there are psychedelics out there with the potential to go mainstream. These include Ketamine and MDMA.

Ketamine, also known as Special K, has been legally used as an anesthetic by veterinarians and as a component in therapy for treatment-resistant depression; it is known to treat anxiety as well.

However, as a drug itself, it is also known to be highly addictive. It also exposes the user to dissociative experiences that affect aspects of memory. The effects are contrary to MDMA’s, who concentrate in the increasing of dopamine, norepinephrine, and serotonin. 

MDMA (a.k.a. ectsasy, molly) is making its mark through The Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is currently testing MDMA in its Phase Three trials.

The organization states that:

“We are studying whether MDMA-assisted psychotherapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. We also sponsored completed studies of MDMA-assisted psychotherapy for autistic adults with social anxiety, and MDMA-assisted psychotherapy for anxiety related to life-threatening illnesses.” 

Despite the benign effects of the stimulant, there is the argument regarding its level of addiction and the effects of withdrawal. According to the National Institute On Drug Abuse, these reported effects include fatigue, loss of appetite, depression, and trouble concentrating.

While the FDA approves dubious items and studies including notorious drugs, the safety of the consumer is put to the test. Drug dependency has been linked more and more with Big Pharma.

The fairness of these drugs’ speedy trials unfortunately leaves little evidence of how effective these treatments truly are. 

Argenis Ovalles is an Editorial Intern at Grit Daily. He currently writes at Vocal Media and Theater Pizzazz.

Read more

More GD News