logo
New Investigational Drug TB006 FDA – Approved For Compassionate Use

New Investigational Drug TB006 FDA – Approved For Compassionate Use

Naples, FL - April 21, 2025 - TB006, a new investigational drug, has been approved by the US Food and Drug Administration (FDA) for compassionate use and is currently being evaluated in a clinical trial for Alzheimer's disease. The FDA's compassionate use designation allows patients with serious or life-threatening conditions to access investigational treatments when no satisfactory alternatives are available.
TB006 is currently undergoing clinical trials to assess its safety and potential effects on inflammation and cognitive function in individuals diagnosed with Alzheimer's disease. According to clinical investigators involved in early-stage research, the drug has been administered to over 300 patients to date, with no adverse side effects reported.
Preliminary data from a placebo-controlled trial suggested that:
These findings are currently being further investigated through ongoing clinical studies. With Alzheimer's disease on the rise, this is very exciting news for those over age 65 and those with a history of dementia in their family.
Among the clinical sites authorized to provide TB006 under compassionate use is Brain Power Clinics, located in West Palm Beach, Florida. The clinic is led by Dr. Joshua Helman, a Harvard-trained physician with over a decade of experience focused on integrative approaches to cognitive decline. Known to patients as Dr. Josh, he currently administers TB006 under FDA protocols as part of a broader, individualized care model.
Dr. Helman works in partnership with Dr. Robert Love, Ph.D., a neuroscientist recognized for his contributions to the field of Alzheimer's prevention and brain health. Together, the team at Brain Power Clinics offers a multidisciplinary approach that combines investigational therapies like TB006 with behavioral coaching and lifestyle interventions designed to support cognitive function.
Participation in the compassionate use program is limited to individuals who meet specific eligibility criteria, which include age and diagnosis parameters in accordance with FDA and clinical trial guidelines.
To learn more about working with Dr. Josh in his medical clinic, please text 'Memory' to 561-725-3319 or visit www.BrainPowerClinics.com.
Disclaimer:
Media Contact
Company Name: Brain Power Clinics
Contact Person: Robert Love
Email: Send Email
Phone: 305-209-0853
Country: United States
Website: http://www.BrainPowerClinics.com/
Source: Brand Featured

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

‘Gas station heroin' is technically illegal and widely available. Here are the facts
‘Gas station heroin' is technically illegal and widely available. Here are the facts

Los Angeles Times

time6 hours ago

  • Los Angeles Times

‘Gas station heroin' is technically illegal and widely available. Here are the facts

WASHINGTON — Health officials want you to think twice before buying one of those brightly colored little bottles often sold at gas stations, convenience stores and smoke shops. Sometimes called 'gas station heroin,' the products are usually marketed as energy shots or cognitive supplements but actually contain tianeptine, an unapproved drug that can be addictive and carries risks of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. And last month the Food and Drug Administration sent a warning to health professionals about 'the magnitude of the underlying danger or these products.' Here's what to know about gas station heroin. Tianeptine is approved in a number of foreign countries as an antidepressant, usually as a low-dose pill taken three times a day. But it has never been approved by the FDA for any medical condition in the U.S. Additionally, the drug cannot legally be added to foods and beverages or sold as a dietary supplement — something the FDA has repeatedly warned U.S. companies about. Still, under-the-radar firms sell tianeptine in various formulas, often with brand names like Zaza, Tianaa, Pegasus and TD Red. Although that is technically illegal, the FDA does not preapprove ingredients added to supplements and beverages. 'It's kind of this gray area of consumer products, or supplements, where the contents are not regulated or tested the way they would be with a medication,' said Dr. Diane Calello of the New Jersey Poison Information and Education System. Last year, Calello and her colleagues published a study documenting a cluster of emergency calls in New Jersey tied to a flavored elixir called Neptune's Fix. People experienced distress, rapid heartbeat, low blood pressure and seizures after drinking it. More than a dozen of the 20 patients had to be admitted for intensive care. Many tianeptine products claim — without evidence or FDA approval — to help users treat medical conditions, including addiction, pain and depression. In 2018, the FDA issued a warning letter to the maker of a product called Tianna, which claimed to provide 'an unparalleled solution to cravings for opiates.' While tianeptine is not an opioid, the drug binds to some of the same receptors in the brain, which can temporarily produce effects akin to oxycodone and other opioids. Tianeptine also carries some of the same physiological risks of opioids, including the potential to dangerously depress breathing. 'That's what tends to get people into trouble,' said Dr. Hannah Hays of Nationwide Children's Hospital in Columbus, Ohio. 'They use it for opioid-like effects or to self-treat opioid withdrawal and that can lead to slow breathing and problems like that.' People dealing with opioid addiction, pain, depression, anxiety and other conditions should see a health professional to get a prescription for FDA-approved treatments, Hays said. Experts aren't sure but national figures show a big rise in emergency calls involving the drug. Calls to poison control centers increased 525% between 2018 and 2023, according to a data analysis published earlier this year. In about 40% of cases, the person had to seek medical care, with more than half of them needing critical care. One explanation for the rise in calls is simply that more Americans are using the products. But experts also say that the products are triggering more emergencies as they become more potent and dangerous. And the researchers in New Jersey who analyzed Neptune's Fix found that the liquid also contained synthetic cannabis and other drugs. 'You never quite know what's in that bottle,' Calello said. 'It's important for people to know that even if they have used a product before, they could get a bottle that contains something very different from what they're looking for.' Tianeptine is not included in the federal Controlled Substances Act, which bans or restricts drugs that have no medical use or have a high potential for abuse, such as heroin, LSD and PCP. But about a dozen states have passed laws prohibiting or restricting tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee. In some cases, those laws have led to more cases of withdrawal among users of tianeptine, which can be chemically addictive. But state data also show some success in reducing harm tied to the drug. Until recently, Alabama had the highest rate of tianeptine-related calls in the southern U.S., which increased more than 1,400% from 2018-21. But after the state restricted tianeptine in 2021, calls began modestly decreasing while calls across other Southern states continued to climb. Perrone writes for the Associated Press.

Popular Dried Fruit Recalled From 19 States for ‘Possible Health Risk
Popular Dried Fruit Recalled From 19 States for ‘Possible Health Risk

Yahoo

time7 hours ago

  • Yahoo

Popular Dried Fruit Recalled From 19 States for ‘Possible Health Risk

A recall of more than 300 cases of Floria Dried Apricots is underway due to a "possible health risk," the U.S. Food and Drug Administration said this week. Turkana Food Inc., which is based out of Kenilworth, New Jersey, pulled 352 cases of the dried fruit snack from shelves in 19 states, the FDA announced Thursday. The reason for the recall is that the packaging for the dried apricots did not indicate they contained sulfites. Sulfites are commonly used as a preservative in food and drinks, but some people could have allergic reactions to them. "The recall was the result of a routine sampling performed by the New York State Department of Agriculture and markets which revealed that the finished products contained Sulfites that were not listed on the product labelling," the FDA said. "The company has ceased production and distribution of the products as FDA and the company continue their investigation to correct the issue with the manufacturer." The 200-gram paper packaged apricots were taken off the market in Alabama, California, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas and Virginia. The packages of apricots contain the lot number '440090478-15-333' and universal package code label '2539560010." They list their expiration date as November 2026, per the recall notice. Anyone who bought the recalled apricots can return them to the place of purchase for a full refund. As of now, no illnesses have been reported. Popular Dried Fruit Recalled From 19 States for 'Possible Health Risk first appeared on Men's Journal on Jun 14, 2025

Dr Pepper Has Recalled Thousands of Cases of Soda
Dr Pepper Has Recalled Thousands of Cases of Soda

Yahoo

time9 hours ago

  • Yahoo

Dr Pepper Has Recalled Thousands of Cases of Soda

In perhaps the funniest mislabeling blunder ever, Pepsi Beverages Company is recalling over 19,000 cases of Dr Pepper Zero Sugar products because they actually do, in fact, contain sugar. Whoops! The Class II recall has a low risk of serious health consequences, but temporary or reversible effects may occur, according to the FDA. To date, no illnesses or adverse reactions have been reported. While the recall pertains to a large amount of product, the sodas in question were only distributed to retail locations in three states—Florida, South Carolina, and Georgia. The affected products were packaged in 12 fl oz. aluminum cans in both 12-pack and 24-pack cartons and have a "best by" date of February 16, 2026 and product code XXXXRS05165. While the average consumer might not have issues with accidentally consuming these mislabeled products, the error could indeed pose health risks for people with diabetes or anyone with conditions instructed to monitor their sugar intake. A can of regular Dr Pepper contains 39 grams of sugar, while Dr Pepper Zero Sugar, obviously is meant to contain zero. The latter does, however, contain artificial sweeteners and additional ingredients like aspartame, acesulfame potassium, and sodium phosphate. Good thing we have a doctor in the house. All recalled products should either be thrown away or returned to your place of purchase. You Might Also Like Can Apple Cider Vinegar Lead to Weight Loss? Bobbi Brown Shares Her Top Face-Transforming Makeup Tips for Women Over 50

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store