Phentermine/topiramate

New Study Confirms Phenomix Sciences' Hungry Brain Test Identifies Abnormal Satiation and Predicts Response to Qsymia

Retrieved on: 
Wednesday, October 18, 2023
Patient, FDA, Physiology, Biomarker, Obesity, Weight loss, Physician, The Hungry Brain, Satiation, Phenotype, Research, Observation, Mayo Clinic, Machine learning, Gene, AI, Timothy, Medical imaging, Phentermine/topiramate

MENLO PARK, Calif., Oct. 18, 2023 /PRNewswire/ -- Results from a new obesity study conducted at Mayo Clinic to assess the utility of the Phenomix Sciences MyPhenome Hungry Brain test were presented at ObesityWeek 2023 by Mayo Clinic's Dr. Diego Anazco, M.D., research postdoctoral fellow in the lab of Dr. Andres Acosta, M.D., Ph.D. The study demonstrated that Phenomix's Hungry Brain biomarker test could predict both the Hungry Brain phenotype and identify high responders to phentermine-topiramate (phen-top, e.g., Qsymia), an FDA-approved anti-obesity medication for weight loss.

Key Points: 
  • The study demonstrated that Phenomix's Hungry Brain biomarker test could predict both the Hungry Brain phenotype and identify high responders to phentermine-topiramate (phen-top, e.g., Qsymia), an FDA-approved anti-obesity medication for weight loss.
  • The study used a cohort of data from a 12-month randomized control trial of patients on Qsymia to assess the MyPhenome Hungry Brain test.
  • the Hungry Brain phenotype), measured by calories to fullness, and the biomarker test identified patients who can achieve greater total body weight loss (TBWL) when treated with Qsymia.
  • Phenomix released its first two MyPhenome tests for Hungry Gut and Hungry Brain biomarkers this year.

World Obesity Market Spotlight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 24, 2022
Health, Other Health, Ageing, NDA, Probability, Clinical trial, Obesity, PDUFA, Dopamine, AstraZeneca, Norepinephrine, Prevalence, CHMP, Patent, Novo Nordisk, Acquisition, Pharmaceutical industry, EU, Semaglutide, Phentermine/topiramate

The "Market Spotlight: Obesity" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Obesity" report has been added to ResearchAndMarkets.com's offering.
  • This Market Spotlight report covers the Obesity market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, key upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • Novo Nordisk has the highest number of completed clinical trials for obesity, with 82 trials.
  • Novo Nordisk leads industry sponsors with the highest overall number of clinical trials for obesity, followed by AstraZeneca.

VIVUS Completes Enrollment in Phase 4 Safety and Efficacy Study of Qsymia® in Adolescents

Retrieved on: 
Monday, March 2, 2020
Drugs, Anorectics, Health, Medicine, Phentermine/topiramate, Vivus, Anti-obesity medication, Food and Drug Administration

Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.

Key Points: 
  • Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.
  • We believe that Qsymia has significant clinical and commercial potential, and we are committed to capturing a larger share of the global market for anti-obesity medications, said John Amos, Chief Executive Officer at VIVUS.
  • In December 2019 , VIVUS reported that data from a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT# 02714062)conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study demonstrated that Qsymia has favorable PK, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.
  • Food and Drug Administration(FDA) required as part of the approval of Qsymia in 2012, enrolled approximately 200 patients at 26 clinical sites inthe United States.

VIVUS Announces Commercial Launch of Qsymia® in the Republic of Korea Establishing New Royalty Revenue Stream

Retrieved on: 
Wednesday, February 19, 2020
Drugs, Anorectics, Combination drugs, Medicine, Phentermine/topiramate, Vivus, Royalty payment, Forward-looking statement

We are confident in Alvogens ability to make Qsymia a significant product in the South Korean market.

Key Points: 
  • We are confident in Alvogens ability to make Qsymia a significant product in the South Korean market.
  • Under the agreement, VIVUS is also eligible to receive royalties on Alvogen's net sales of Qsymia and future milestone payments contingent upon achievement of net sales goals within the covered territory.
  • Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy.
  • These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements.

New Data Further Demonstrate Effectiveness of VIVUS’ Qsymia as a Weight Management Tool

Retrieved on: 
Tuesday, January 7, 2020
Drugs, Human weight, Anorectics, Phentermine/topiramate, School voucher, Phentermine, Voucher, WW International, Weight management

The Toolbox Trial was designed to provide insight into treatment choices and outcomes when patients are offered a variety of low out-of-pocket cost weight management options.

Key Points: 
  • The Toolbox Trial was designed to provide insight into treatment choices and outcomes when patients are offered a variety of low out-of-pocket cost weight management options.
  • The services included partial meal replacement, recreation center membership, phentermine, Qsymia, Weight Watchers vouchers and group behavioral weight loss program.
  • At each monthly visit, patients had the option of continuing with the initial tool selected or switching to a different tool.
  • After six months, patients could pay an additional $5 per month to add recreation center vouchers or a behavioral weight loss program.

VIVUS Announces New Data Supporting the Safety and Efficacy of Qsymia® in Adolescents with Obesity

Retrieved on: 
Wednesday, December 18, 2019
Drugs, Medicine, Clinical medicine, Anorectics, Phentermine/topiramate, Vivus, Amphetamine, Obesity, Dose

The study was conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study of Qsymia in obese adolescents.

Key Points: 
  • The study was conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study of Qsymia in obese adolescents.
  • Eligible participants were randomly assigned in a 1:1:1 ratio to placebo, mid-dose Qsymia or top-dose Qsymia.
  • The primary objective of the study was to describe the PK profiles of Qsymia after administration in adolescents with obesity.
  • These findings add to the growing body of data supporting the safety and clinical benefit of Qsymia in diverse patient populations, said John Amos, Chief Executive Officer at VIVUS.

New Clinical Data Demonstrate VIVUS’ Qsymia® is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa

Retrieved on: 
Wednesday, November 20, 2019
Eating disorders, Human behavior, Hyperalimentation, Health, Psychiatry, Abnormal psychology, RTT, Psychiatric diagnosis, Binge eating disorder, Binge eating, Phentermine/topiramate, Vivus

The primary outcome was the number of objective binge-eating (OBE) days over four weeks; secondary outcomes included binge abstinence.

Key Points: 
  • The primary outcome was the number of objective binge-eating (OBE) days over four weeks; secondary outcomes included binge abstinence.
  • Demographics, vital signs, eating disorder behaviors, mood and side effect data were also collected.
  • Binge eating returned and abstinence rates decreased during the eight-week post-treatment follow-up period, suggesting that additional approaches to improved maintenance are needed.
  • These data further validate the clinical utility of Qsymia in helping patients with a variety of weight-related health conditions to achieve healthier eating behaviors, said John Amos, Chief Executive Officer at VIVUS.

DietDemand Advises Consumers Regarding Popular Weight Loss Prescription for Binge Eaters

Retrieved on: 
Wednesday, October 9, 2019
Drugs, Medicine, Clinical medicine, Anorectics, RTT, Combination drugs, Norepinephrine releasing agents, Amphetamine, Phentermine/topiramate, Anti-obesity medication, Topiramate, Phentermine

Topiramate is one ingredient in the FDA approved weight loss drug Qsymia.Qsymia is a combination of Phentermine and Topiramate which is proven to help with weight loss.

Key Points: 
  • Topiramate is one ingredient in the FDA approved weight loss drug Qsymia.Qsymia is a combination of Phentermine and Topiramate which is proven to help with weight loss.
  • For anyone who is looking for a more permanent solution to binge or emotional eating, DietDemands comprehensive, doctor-supervised weight loss plan offer personalized diet coaching to identify weight loss obstacles and retrain clients in order to produce long-term weight loss.
  • DietDemand is the nation's leader in medical, weight loss offering a full line of prescription medication, doctor, nurse and nutritional coaching support.
  • For over a decade, DietDemand has produced a sophisticated, doctor designed weight loss program that addresses each individual specific health need to promote fast, safe and long-term weight loss.

VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe

Retrieved on: 
Monday, October 7, 2019
Drugs, Medicine, Clinical medicine, Marketing authorization, Pharmaceutical industry, Pharmaceuticals policy, Anorectics, Vivus, Maa, Amphetamine, Phentermine/topiramate, Obesity

Under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries.

Key Points: 
  • Under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries.
  • We believe that Qsymia has an important role to play in addressing the growing challenge of obesity in the United States, Europe, and other markets.
  • Based on the decentralized MAA procedure timelines, the Company anticipates the completion of the MAA assessment and, if approved, Marketing Authorizations to begin in the second half of 2020.
  • VIVUS does not undertake an obligation to update or revise any forward-looking statements.

VIVUS to Share Qsymia® Safety and Efficacy Data with a Global Audience at ICOMES & AOCO 2019

Retrieved on: 
Tuesday, August 27, 2019
Drugs, Medicine, Clinical medicine, Anorectics, RTT, Amphetamine, Vivus, Combination drugs, Phentermine/topiramate, Norepinephrine releasing agents, Phentermine, Topiramate

Dr. Varghese will give two presentations summarizing previously reported safety and efficacy data for Qsymia (phentermine and topiramate extended-release) capsules CIV.

Key Points: 
  • Dr. Varghese will give two presentations summarizing previously reported safety and efficacy data for Qsymia (phentermine and topiramate extended-release) capsules CIV.
  • With Alvogens recent receipt of approval of Qsymia by the South Korea Ministry of Food and Drug Safety, this an opportune time for us to educate physicians in Korea and other global regions about the robust body of data supporting the safety and efficacy of Qsymia.
  • Dr. Varghese will make the following presentations:
    Optimizing clinical outcomes in obese and overweight patients with combination phentermine plus topiramate extended release.
  • VIVUS is committed to realizing the full clinical and commercial potential of Qsymia in the U.S. and in our international markets.