Promising New PTSD Drug Flops

Jazz Pharmaceuticals had high hopes for its new fatty acid amide hydrolase (FAAH) inhibitor, but the drug failed to outperform a placebo during a clinical trial.

“We plan to fully evaluate this data. However, based on topline results, we do not anticipate moving forward with additional JZP150 development in PTSD,” Rob Iannone, M.D., Jazz’s global head of R&D, said. “We recognize the significant unmet need for PTSD patients and plan to share the findings from this trial with the medical community at a future date,” he added.

Jazz had high hopes for JZP150, having previously pointed out that it had a chance of becoming the first new drug approved in twenty years for patients with the disorder. PTSD has been in the headlines recently as the Multidisciplinary Association for Psychedelic Studies’ submitted a new drug submission for MDMA to treat the condition, marking the first time ever that the agency will consider approving a psychedelic-assisted therapy.

The Science of Post-Traumatic Stress Disorder

Post Traumatic Stress Disorder is not a “disorder.” Doctors often use this word to describe a psychological condition of unknown origin. Schizophrenia was once a disorder. Other times, a “disorder” shifts responsibility, at least according to some. For example, once again, according to some, attention deficit disorder blames a child for not responding to a teacher’s uninspired classroom tactics.

Until recently, PTSD mostly fit into the first “disorder” category. No one knew why missing brains plagued PTSD victims. The second category applied as well. “It’s not your fault you cannot deal with a traumatic memory because you have Post Traumatic Stress Disorder.”

Today, it is clear that PTSD is not a disorder in either sense of the word. Although the science is still developing, researchers know what causes this brain injury. Extreme stress changes the brain’s chemical composition.

Proper responses to everyday situations depend on a proper balance between the amygdala (part of the brain that controls emotional responses) and hippocampus (logical responses). When someone brings donuts to a morning meeting, my amygdala prompts me to eat as many as I want, and my hippocampus prompts me to eat none.

Since I am a reasonably balanced individual, I compromise and eat one or maybe two. However, if I had an enlarged amygdala, no one else would get any donuts. This entire thought process takes less than a blink of an eye. It is incredible how fast our brain works and how delicate it is.

Poor decision-making is only part of the trouble. An out-of-control amygdala also has side effects, such as:

  • Hypervigilance,
  • Anger,
  • Nightmares,
  • Depression, and
  • Flashbacks.

Here is where the science gets a little shaky. These symptoms are natural reactions to stress. At some point, NSR (normal stress response) becomes PTSD. No one is sure where to draw that line.

PTSD treatment is uncertain as well. Some combination of drugs and therapy works for everyone. Many people thought a fatty acid amide hydrolase inhibitor was a magic bullet that addressed this issue.

The endocannabinoid system regulates anxiety and fear responses. So, blocking excess FAAH production meant reducing fear and anxiety. The idea looked great on paper, but it just didn’t pan out in practice. So, the quest for a magic bullet PTSD drug continues.

Combat-Related PTSD

A one-time stressful event causes uncomplicated PTSD. The cumulative effects of lesser stressful events (non-life-threatening events) cause complicated PTSD. Contractors are at risk for both kinds.

Whether they are on duty or off duty, soldiers, including private military contractors, are always uneasy. That is especially true in anti-insurgency campaigns. Any car on the road could carry a bomb, anyone on the street could be wearing a bomb, and anyone using a cell phone could be triggering an IED. We have no idea what it’s like to go to the grocery store or go to work and know you might not come home in one piece.

The stress of a life-threatening situation is enough to push anyone over the edge. The fight-or-flight hormones, adrenaline, noradrenaline, and cortisol, are out of control. These powerful hormones are responsible for many brain injuries.

Generations of soldiers have dealt with these brain injuries. But until recently, as mentioned above, doctors did not fully understand why. Battle fatigue, the World War II-era name for PTSD, is a good example.

At many points of this conflict, about half the soldiers in field hospitals were diagnosed with battle fatigue. Doctors believed after these individuals got a few hours of rest and a lot of fluids, they could go back to the front line. Doctors did not know that the constant stress of front-line duty, along with occasional extreme stress, caused battle fatigue in the first place.

A “battle fatigue” diagnosis is now a thing of the past. Recently, the Canadian Armed Forces dropped the PTSD label and replaced it with OSI (operational stress injury), a designation that better reflects the medical nature of PTSD.

Injury Compensation Available

The good news is that doctors can now properly diagnose PTSD and formulate a treatment plan. The bad news is that this medical treatment is very expensive, and most private military contractors don’t have health insurance.

Defense Base Act benefits cover expensive prescription drugs as long as they are reasonably necessary. This requirement sometimes creates issues when doctors prescribe cutting-edge medicine that is new to the market, especially when a cheaper and similar drug is available.

We mentioned PTSD diagnosis issues above. Some doctors still cling to the old ways of “battle fatigue” and other PTSD substitutes. So, a Defense Base Act lawyer must connect a PTSD victim with a doctor who focuses on these kinds of head injuries. This process is easier in these cases. Usually, injured overseas contractors can choose their own doctors.

The medical bill benefit also applies to all other reasonably necessary expenses, such as:

  • Transportation: This bill is often significant in traumatic brain injury (TBI) cases. Most field hospitals don’t have the staff or equipment to treat such injuries. Therefore, victims must be transported to a larger facility that’s usually hundreds of miles away.
  • Surgical Treatment: Unfortunately, surgeons cannot correct chemical imbalances in the brain. But they can address brain bleeding and swelling, two classic TBI effects. This bleeding and swelling eventually becomes fatal.
  • Follow-Up Treatment: This treatment usually includes prescription drugs, which were mentioned above, as well as other expensive ancillary treatments, such as medical devices and treatment such as physical therapy.

Medical bill payments are important, but they are a bit empty without the lost wage replacement benefit. The world keeps turning after an injury, which means regular bills must be paid. Usually, the Defense Base Act pays two-thirds of the victim’s Average Weekly Wage for the duration of a temporary or permanent disability.

PTSD is usually permanently debilitating. The treatment/therapy combination manages PTSD symptoms but does not cure the disease

For more information about DBA eligibility, contact Barnett, Lerner, Karsen, Frankel & Castro, P.A.