"In the works for people flocking to Ozempic to shed lots of pounds: weight-loss medicines that come in a pill.
Drugs such as Ozempic that have surged in popularity for weight loss must be injected. Yet many people despise needles, prompting drugmakers to explore formulations that could be swallowed.
The chemistry isn't simple. But if researchers can pull it off, the tablets could appeal to the sizable number of people who fear needles, while costing hundreds of dollars less than their injected cousins.
The hunt for tablet versions of the injectable weight-loss medicines is among the hottest areas of drug research, attracting industry heavyweights like Eli Lilly, Novo Nordisk and Pfizer and fueled by a potential multibillion-dollar market.
Farthest along is a tablet form of semaglutide -- a main ingredient in the injections -- developed by Novo Nordisk.
The experimental pill helped people who took it daily for 68 weeks as part of a study lose up to 17.4% of their body weight, Novo Nordisk said in May. The reduction was similar to what testing found for Ozempic's cousin, the drug Wegovy.
Later this year, Novo Nordisk plans to ask U.S. and European drug regulators to approve the tablet.Novo sells a tablet form of semaglutide, Rybelsus, to treat Type 2 diabetes, though some people use it off-label for weight loss.
Novo Nordisk's Ozempic and Wegovy therapies and Lilly's Mounjaro have emerged as viral sensations -- touted by celebrities and discussed on Facebook and TikTok -- because of their potential to help people lose significant weight.
These types of drugs, first approved to treat diabetes, work by mimicking gut hormones that play a role regulating blood sugar and, it turned out, appetite. A key gut hormone is called glucagon-like peptide-1, or GLP-1.
Peptides are large molecules, which are easier to package and deliver as an injection. Drugmakers have made their GLP-1 drugs into injections so they avoid the journey of pills, which travel through the digestive tract because they are swallowed. The digestive tract can degrade peptides, minimizing their benefits.
But manufacturing the peptides and the devices, known as pens, to inject them is expensive and complex.
Injectable drugs must be stored at certain, often cold, temperatures. And they strike fear in a small but significant group.
"Some people are just needle-phobic,"said BMO Capital Markets analyst Evan David Seigerman.
Analysts project the anti-obesity medicine market will be so large that drugmakers have launched efforts to find tablets that would appeal to those who don't want to be injected.
Seigerman estimated that pill forms of weight-loss drugs could make up about 15% of the total market, which he predicts will reach $100 billion in annual sales worldwide in coming years.
Drugmakers have designed the oral versions of the gut-hormone drugs to overcome digestive-tract degradation by either using a higher dose than the injected drugs or by using a non-peptide form of gut hormone.
Given the chemistry, pill forms aren't likely to surpass the weight loss that can be achieved with the current once-weekly injections, doctors and analysts said.
Some tablets might even deliver inferior weight loss. And some patients might prefer the convenience of a once-weekly injection over a daily pill.
"I'm just guessing people will say, 'You know that once a week sounds much simpler,'" said Dr. Robert Kushner, an obesity-treatment specialist at Northwestern University Feinberg School of Medicine.
Yet the pills could prove attractive to a segment of patients if priced less, according to analysts and doctors.
A pill being developed by Structure Therapeutics could be priced at about $500 a month if it succeeds in testing and is approved by regulators, Seigerman estimated, roughly half the cost of the injected drugs.
Structure Chief Executive Raymond Stevens said it was too early to discuss a specific price, but the company's goal is to price the drug to make it accessible to patients.
"If these oral medications are more affordable or more accessible, that could be where they could fill that gap," said Dr. Ania Jastreboff, director of the Yale Obesity Research Center in New Haven, Conn.
Eli Lilly is developing a non-peptide GLP-1 pill called orforglipron.
The once-daily pill, taken for 36 weeks, helped volunteers lose up to 14.7% of their body weight in a mid-stage clinical trial of more than 270 people with obesity, researchers reported Friday at the annual meeting of the American Diabetes Association in San Diego.
That was a loss of about 35 pounds for a person in the study who had the average starting weight of 240 pounds.
Lilly recently started a larger, late-stage clinical trial of the pill, in hopes of generating sufficient evidence for approval.
The company has said its GLP-1 pill is unlikely to help people lose as much weight as its injected drug Mounjaro, which adds a second gut hormone, GIP, to GLP-1.
In one study, patients taking Mounjaro lost up to about 22.5% of their body weight.
If the experimental pill can match the GLP-1-only injected drugs, however, it could be an option for some patients.
Pfizer is developing anti-obesity pills including danuglipron, which showed promise in a mid-stage study reported earlier this year.
In testing, the pill versions of the weight-loss injections come with similar gastrointestinal side effects such as nausea for some patients.
The companies have said the events are generally mild to moderate and typically occurred when doses were increased." [1]
1. Pill Versions of Ozempic-Like Drugs Are in the Works. Loftus, Peter.
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 26 June 2023: B.1.
Komentarų nėra:
Rašyti komentarą