When the Meals and Drug Administration (FDA) authorized Byetta (exenatide) in 2005, medical doctors thought it was simply approving the primary glucagon-like peptide-1 (GLP-1) agonist to deal with Sort 2 diabetes. However this new drug class had the potential to deal with a bunch of different issues.
GLP-1 agonists mimic the physique’s intrinsic GLP-1, a hormone that stimulates insulin launch, suppresses the hormone glucagon, slows the muscle tissues that transfer meals via the intestinal tract, and reduces urge for food. GLP-1s not directly trigger weight reduction by slowing the motion of meals via the abdomen and intestines, extending the sensation of fullness. Researchers quickly found additionally they instantly act on GLP-1 receptors within the mind to scale back urge for food and cravings. Throughout medical trials and postapproval surveillance, clinicians seen folks on GLP-1s shedding pounds.
Clinicians started prescribing GLP-1s off-label—not for a goal or in a dose the FDA particularly authorized—quickly after seeing the drug’s weight reduction results. By 2014, the FDA authorized the GLP-1 Sort 2 diabetes drug Victoza (liraglutide) to deal with weight problems below a distinct model identify, Saxenda. Each manufacturers comprise the identical drug however have totally different dosing directions. Since then, different drug producers have adopted the identical technique.
The makers of the GLP-1 Ozempic(semaglutide) acquired the FDA to approve the identical drug in a distinct dose below the identify Wegovy to deal with weight problems. Later, the FDA permitted the makers of Mounjaro (tirzepatide) to promote it for weight reduction as Zepbound. Getting FDA approval for these rebranded merchandise permits drugmakers to make use of present patent legal guidelines to increase their exclusivity for the brand new indication—enabling them to cost greater costs. It additionally makes it simpler for them to safe insurance coverage protection.
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As clinicians and medical researchers realized extra concerning the direct impact that GLP-1s have on meals cravings, they got down to discover if they could assist cut back cravings for different substances and even perhaps assist folks with substance-use problems.
A 2023 research discovered that folks utilizing GLP-1 drugs for weight reduction additionally drank much less alcohol. Extra lately, analysis co-authored by Nationwide Institute on Drug Abuse Director Nora Volkow urged that GLP-1 agonists may assist stop relapse in these with alcohol-use dysfunction. Collectively, these findings counsel that the medication could cut back alcohol cravings.
Volkow and colleagues printed a research in 2024 suggesting GLP-1s may also cut back the need to eat hashish. There’s anecdotal proof they could even reduce nicotine cravings.
There’s rising proof that GLP-1s can equally cut back cravings for opioids. If that’s the case, GLP-1s can complement or, in some conditions, exchange methadone and buprenorphine, two confirmed drugs for opioid-use dysfunction. Even when they solely work along side methadone or buprenorphine, they could cut back sufferers’ dose necessities and reliance on them.
Much more thrilling, there’s early proof that GLP-1 would possibly cut back cravings for stimulants corresponding to cocaine and methamphetamine. Presently, there are not any drugs for stimulant-use problems.
Some researchers at the moment are trying into whether or not GLP-1s can cut back compulsive habits, together with compulsive playing.
GLP-1s should not with out dangers. Along with widespread uncomfortable side effects corresponding to nausea and diarrhea, these medication can sometimes trigger pancreatic irritation and, in very uncommon circumstances, are linked to a uncommon type of thyroid most cancers in folks with a genetic predisposition.
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As I clarify in my e-book Your Physique, Your Well being Care, in 1951 Congress gave the FDA unique energy to resolve which medication producers may promote over-the-counter (OTC) and which of them adults may solely buy with a prescription—a permission slip from a government-licensed well being care supplier. Earlier than that regulation, producers made these choices. In the event that they believed a drug was too advanced or carried a excessive danger of misuse, they’d select to have it offered by prescription solely, partly to guard themselves from legal responsibility.
If Congress eliminated the FDA’s monopoly energy to require prescriptions, it’s potential that some 20 years after GLP-1s appeared available on the market, competitors from new manufacturers will incentivize some makers of GLP-1 merchandise to market them over-the-counter.
Ibuprofen carries the dangers of kidney harm, hypertension, ulcers, and cardiovascular occasions. The FDA authorized ibuprofen as a prescription drug in 1974. Ten years later it eliminated obstacles to folks shopping for it over-the-counter. If adults are competent to purchase and use ibuprofen with correct labeling directions after 10 years, why cannot they use GLP-1s with correct labeling directions after 20 years?
Think about how folks would profit if they might purchase GLP-1s over-the-counter. Medication are typically dramatically inexpensive when they’re accessible OTC. Prescribed drugs normally carry greater value tags than do OTC merchandise, primarily as a result of insurance coverage covers prescriptions however not OTC purchases. When folks pay out of pocket, they search for higher offers, which pressures corporations to maintain costs aggressive. As soon as insurance coverage takes over the price, buyers cease listening to value and drugmakers can cost the deeper-pocket third-party payers extra with out worrying about dropping prospects.
If individuals are nervous they is perhaps consuming an excessive amount of alcohol, utilizing an excessive amount of hashish, or hooked on opioids, meth, or cocaine, would not or not it’s nice if they might merely purchase a GLP-1 over-the-counter? This manner they might, if GLP-1s’ results in these areas pan out, privately and discreetly cut back their substance use to a safer stage with out dealing with any stigma.
Till adults can get these medication over-the-counter, eradicating the FDA’s restrictions on compounding pharmacies can go a great distance towards making GLP-1s inexpensive. Below the Meals, Drug, and Beauty Act of 1938 and its amendments, compounding pharmacists could make and promote merchandise to customers without having FDA approval, so long as they use FDA-approved elements from licensed amenities. However the FDA prohibits pharmacies from creating medication that “primarily copy” commercially accessible ones—although this restriction is lifted throughout essential product shortages.
After the FDA authorized Wegovy for weight reduction, demand for this and different GLP-1s soared, leading to shortages of the FDA-approved manufacturers. In late 2022, the FDA declared a scarcity of Zepbound, Wegovy, and different GLP-1s and allowed compounding pharmacies to create important copies. These pharmacies helped enhance affected person entry to those efficient medication at considerably decrease costs than the commercially manufactured variations.
In February 2025, the FDA introduced that the scarcity was “resolved.” This implies customers will return to paying extra for the commercially accessible product. The upper costs could pressure some folks to cease taking the drug altogether. Compounding pharmacies are exploring options, corresponding to creating merchandise with totally different doses or supply methods than these utilized in commercially accessible medication.
A method to enhance the state of affairs could be for Congress to take away FDA obstacles to compounding pharmacies making merchandise which might be primarily copies of commercially accessible off-patent merchandise.
Think about a future the place GLP-1s are readily accessible—via compounding pharmacies or OTC choices—providing hope and therapeutic to thousands and thousands. For these battling weight problems or substance-use problems, these drugs may change into life-changing instruments for reclaiming well being and alternative. Reaching that future would require daring coverage choices that raise unnecessary restrictions and put transformative care inside everybody’s attain.
This text initially appeared in print below the headline “Unlocking the Full Potential of GLP-1s.”
