These popular antidepressants cause the most weight gain

 Lexapro, Paxil and Cymbalta carry a higher risk of packing on pounds than Zoloft, while Wellbutrin users are less likely to gain weight, according to a new study of eight popular antidepressants.

Harvard Pilgrim Health Care Institute (HPHCI) researchers analyzed the weights of more than 183,000 adult antidepressant users six months, a year and two years after they started taking the drugs.

At six months of usage, Lexapro, Paxil and Cymbalta users were 10% to 15% more likely to gain at least 5% of their starting weight than Zoloft consumers, the study found.PRN

Data from taking Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), Paxil (paroxetine), Wellbutrin (bupropion), Cymbalta (duloxetine) and Effexor (venlafaxine) was compared to Zoloft (sertraline), which is the most prescribed antidepressant in the US.

At six months, Lexapro, Paxil and Cymbalta users were 10% to 15% more likely to gain at least 5% of their starting weight than Zoloft consumers.

Prozac was not associated with a six-month weight change, while Wellbutrin users were 15% less likely to experience a 5% weight gain. Wellbutrin continued to be associated with the least weight gain at the one- and two-year marks.

Wellbutrin was associated with the least weight gain at the six-month, one- and two-year marks.Getty Images

The findings were published this week in the Annals of Internal Medicine.

The researchers credited Wellbutrin’s ability to increase levels of dopamine and norepinephrine in the brain, which improve wakefulness and alertness.

The drug — used to treat depression and seasonal affective disorder and help people stop smoking — has also been shown to stimulate the central melanocortin system, which regulates appetite, energy balance and body weight.

The study results come amid growing antidepressant use, especially among young adults and teens.

One study found that about 14% of US adults take an antidepressant. The HPHCI researchers noted that people often stop using the drug if they experience weight gain.

“This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants,” said lead author Joshua Petimar, a Harvard Medical School assistant professor of population medicine.

“Clinicians and patients can use this information, among other factors, to help decide on the right choice for them,” he added.

Greatest risk of at least 5% weight gain at six months of use

• Lexapro
• Paxil
• Cymbalta
• Effexor
• Celexa
• Zoloft (baseline)
• Prozac
• Wellbutrin

https://nypost.com/2024/07/01/lifestyle/popular-antidepressants-that-cause-most-weight-gain-study/

Heron Acceptance of Prior Approval Supplement Application for Vial Access Needle

 -The U.S. Food and Drug Administration ("FDA") assigned a Prescription Drug User Fee Act ("PDUFA") goal date of September 23, 2024

Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement ("PAS") application for ZYNRELEF^® (bupivacaine and meloxicam) extended-release solution VAN. The FDA has assigned a PDUFA goal date of September 23, 2024.

If approved, the introduction of the VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time from up to three minutes down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. If approved, the VAN is expected to be available for use in the fourth quarter of this year.

In addition to the anticipated launch of the VAN, the national rollout of the CrossLink Life Sciences, LLC ("CrossLink") partnership continues to make progress and is expected to add ~650 representatives to the promotion of ZYNRELEF by year-end. The Company anticipates that this partnership will be instrumental in successfully launching the VAN to a large base of orthopedic surgeons across the country.

https://www.biospace.com/article/releases/heron-therapeutics-announces-acceptance-of-the-prior-approval-supplement-application-for-zynrelef-vial-access-needle-and-quot-van-and-quot-/

Annovis New Data from Phase III Parkinson’s Study

 Buntanetap showed dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population.  Parkinson’s patients with substantial cognitive decline exhibited a very pronounced improvement.

Buntanetap showed statistical improvement in the MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson’s patients with a >3-year diagnosis.

Buntanetap showed the same statistical improvement in MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson’s patients with Postural Instability and Gait Difficulties (PIGD).

Buntanetap’s activity resulted in statistically significant improvements in all primary and secondary endpoints in the specified populations as well as in cognition.

These findings will be discussed in more detail on today's webcast at 4:30 PM ET. Register here.

FDA and Endpoint Clarification: Recent questions regarding the primary and secondary endpoints in MDS-UPDRS scores warrants additional explanation. Initially, Annovis chose MDS-UPDRS Part II+III as the primary endpoint. However, based on FDA feedback, MDS-UPDRS Part II alone was deemed more appropriate for reflecting clinically relevant changes (Goetz et al., 2023). Consequently, we adjusted our primary endpoint to MDS-UPDRS Part II, with MDS-UPDRS Part III as a key secondary endpoint. Our results met both primary and secondary endpoints in the specified subgroups.

https://www.biospace.com/article/releases/annovis-bio-announces-new-data-from-phase-iii-parkinson-s-study-highlighting-improvements-in-unified-parkinson-s-disease-rating-scale-mds-updrs-and-cognition-after-treatment-with-buntanetap/

To Preserve Patient Access to XPHOZAH®, Ardelyx Chooses Not to File for TDAPA

 Ardelyx continues support for bipartisan legislation that would extend the exclusion of oral-only medications from entering the CMS Prospective Payment System

Conference call scheduled for 8:00 AM Eastern Time

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH® (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA).

Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.

Conference Call Details
The company will host a conference call today, July 2, 2024, at 8:00 am ET to discuss today's announcement. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ardelyx.com/, and will be available on the website for 30 days following the call.

https://www.globenewswire.com/news-release/2024/07/02/2907293/0/en/To-Preserve-Patient-Access-to-XPHOZAH-Ardelyx-Chooses-Not-to-File-for-TDAPA.html

Vertex Acceptance of Application for Triple Combination Treatment for Cystic Fibrosis

 - Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 –

- EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA)

https://www.biospace.com/article/releases/vertex-announces-fda-acceptance-of-new-drug-application-for-vanzacaftor-tezacaftor-deutivacaftor-a-next-in-class-triple-combination-treatment-for-cystic-fibrosis/

Immuron requests pre-IND meeting for IMM-529 with FDA filing

 Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529.

CEO, Steven Lydeamore said, “We are excited for our third therapeutic to be heading towards Phase 2 clinical studies, demonstrating the utility of our technology platform.”

The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.

To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI.

Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).

This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01)and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains.

To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease. https://doi.org/10.1038/s41598-017-03982-5

https://www.biospace.com/article/releases/immuron-requests-pre-ind-meeting-for-imm-529-with-fda-filing/

Cartesian Therapeutics Plummets On 'Watershed Moment' For CAR-T Drugs

 Cartesian Therapeutics (RNAC) reported a "watershed moment" for its autoimmune-disease focused CAR-T treatment on Tuesday, but the biotech stock plunged in premarket trades.

The biotech company tested its drug, Descartes-08, in patients with generalized myasthenia gravis, an autoimmune condition that causes muscle weakness and fatigue. After three months, 71% of patients who received Cartesian's drug achieved at least a five-point improvement on a 50-point scale of symptoms. In comparison, just 25% of placebo recipients hit the same bar.

"These data mark a watershed moment for the field, representing the first-placebo controlled study of a CAR-T cell therapy in autoimmune disease," Leerink Partners analyst Thomas Smith said in a report to clients.

But in premarket trades on today's stock market, the biotech stock plummeted 17.8% to 20.01.

https://www.investors.com/news/technology/biotech-stock-cartesian-therapeutics-car-t-generalized-myasthenia-gravis/