Ectasy-Based PTSD Therapy Nears FDA Approval

Good Morning, it’s June 3, and here are some of the stories we are following:

✔  California Company Nears Historic FDA Approval for Ecstasy-Based PTSD Therapy

✔ A Fast-Food Chain Succumbs to the Impact of Governor Newsom's Minimum Wage Law

✔Another Shark Attack, a swimmer was bitten in the chest off San Diego Beach

✔And there’s another bread battle brewing, this time it doesn’t involve the Governor.

We hope you have a great Monday.

Netter News Team

FDA REVIEWS CALIFORNIA-BASED PSYCHEDELIC TREATMENT

While many of us have been focused on national politics, a California-based company is on the verge of becoming the first in U.S. history to receive FDA approval for an ecstasy-based therapy aimed at treating post-traumatic stress disorder (PTSD).

Historic Review

Tomorrow, the Food and Drug Administration's panel of independent advisers will begin deliberations on whether to recommend approval for Lykos Therapeutics' MDMA-assisted therapy for PTSD.

This also marks the first time in 25 years that an FDA panel of outside experts will review a potential new treatment for PTSD.

The Study

Lykos Therapeutics tested 195 adults with moderate to severe PTSD. The results were mixed, and this will likely require the FDA to carefully weigh the benefits and challenges before making a decision.

Benefits:

🔻Lykos used MDMA tablets, in conjunction with psychotherapy and other supportive mental health services, as a treatment for adults with PTSD.

🔻Those who received MDMA and talk therapy were more likely to be in remission at the end of the trial than those who didn’t.

Challenges:

🔻Due to the drug's well-known psychedelic effects, the control group could easily identify the placebo, which may have influenced the results.

🔻We don’t know how long a patient would need to undergo treatment, considering that 25% of the participants dropped out before the end of a follow-up study.

What are MDMA Tablets

According to Lykos,

• The drug is not a classic psychedelic like LSD or psilocybin.

• MDMA is considered an empathogen or entactogen, meaning it increases an individual’s feeling of empathy and social connectedness.

What’s Next

The FDA’s decision is expected on August 11. Even if it’s approved, hurdles remain:

• the potential for dangerous side effects

• the drug’s accessibility

• the legality of the drug from state to state

• In California, right now it’s illegal, however, in places like San Francisco and Oakland, local leaders have moved to decriminalize possession of psychedelic mushrooms.

More Details, Because it’s Just Interesting….

At the start of 2024,

• Lykos Therapeutics rebranded the company from MAPS PBC.

• The company quietly raised $100 million in funding.

• That’s also when the company submitted its new drug application to the FDA.

POLITICS, ECONOMY, EDUCATION & SCIENCE

FAST FOOD LAW- ANOTHER VICTIM

Another California fast-food chain falls victim to Governor Newsom’s fast food minimum wage law. This time, Rubio’s Coastal Grill has shut down 48 locations across California

What We Know

The company, in a statement, blamed the problem on the ‘unfriendly’ business environment in the state.

A restaurant industry spokesman pointed out:

📌Fast-food chains, like Rubio, were forced to start paying their workers $20 per hour per Newsom’s fast-food minimum wage law back in April.

📌Rubio and other major chains have increased prices by 7-8% to offset the increase in wages.

📌This is a breaking point for many small restaurant businesses.

PRESIDENTA!

Mexico has elected its first female president, shattering gender barriers in a country known for its deeply patriarchal culture. Claudia Sheinbaum is a scientist turned politician and went to college in the Bay area!

Who is Claudia Sheinbaum

• She completed her PhD thesis at the Lawrence Berkeley National Laboratory in Berekely.

• The 61-year-old is also a former mayor of Mexico City

• She has won a Nobel Peace Prize (she shared this with former Vice President Al Gore in 2007).

• She’s also of Jewish ancestry in a highly Catholic country.

HOT TAKES

🚨 HEAT, WIND, AND FIRES: Heat, wind, and fires are gripping many parts of the state on this Monday. In Northern California, a major wildfire has destroyed one home and caused evacuations east of San Francisco near Tracy. We are starting to feel the effects of what could be a long, dry summer in California.

🚨 HUNTER BIDEN TRIAL: For the first time in history, the child of a sitting president is on trial, as Hunter Biden’s felony gun trial starts today in Delaware. Political experts say this could potentially impact his father’s reelection campaign.

🚨TRUMP TIKTOK SURGE: Former President Trump decided he likes TikTok after all. This weekend Trump joined the platform and surpassed President Biden’s followers in just 24 hours (3 Million and counting). Reminder, Trump had wanted to ban TikTok on national security grounds. What a time to be alive.

🚨BREAD BATTLE: We have another battle over bread in California and this time it involves Kroger! Prosecutors say the nation’s largest grocery store operator is misleading shoppers about its Carbmaster bread products.

🚨 99 CENT STORES: Could the popular 99 Cent Only stores reopen as Dollar Tree Stores? The bargain retailer said it had retained the rights for 170 of the 99 Cent Only stores in California and three other states.

GOLDEN STATE GLOW

🌴Okay, we know we said last week that shark attacks were rare in California (they are) but another person was attacked by a shark this weekend in Southern California. This time in Del Mar where two men came to the rescue of the man who was bitten in the chest. Incredibly he will survive.

Officials are not sure if this is the same juvenile white shark that tried to bite a surfer last week off San Clemente.

🌴 Disney fanatics rejoice, an airline is resuming non-stop flights between Disneyland and Walt Disney World. Details on the Orange County - Orlando Express Route are here.

 🗓THIS DAY IN CALI-HISTORY

June 3: 

• On this day in 1943, a mob of about 60 US sailors beat up everyone who they thought to be Mexican Americans wearing so-called “Zoot Suits”, starting what is now known as the “Zoot Suit Riots”. 

• The zoot suit consisted of a broad-shouldered drape jacket, balloon-leg trousers, and, sometimes, a flamboyant hat.

• What occurred that evening of June 3, and in the following days was a series of race riots primarily between servicemen and zoot-suiters. Many ‘zoot suiters’ were beaten by servicemen and stripped of their clothes on the spot.

• On this day in 1985, CNN debuted Larry King Live, which became the network's most-watched and longest-running program, attracting over one million viewers nightly. Primarily broadcast from CNN's Los Angeles studios, the one-hour show aired worldwide until 2010.