FDA Accepts sNDA for Jardiance as Potential Treatment for Chronic Kidney Disease
January 26, 2023 02:12pm
By Ashley Gallagher, Assistant Editor
This weekly video program provides our readers with an in-depth review of the latest news, medical product approvals, FDA rulings, and more. The Week in Review highlights a Contemporary Clinic article each week, and is a can't miss for the busy healthcare professional.
This weekly video program provides our readers with an in-depth review of the latest news, medical product approvals, FDA rulings, and more. The Week in Review highlights aContemporary Clinicarticle each week, and is a can't miss for the busy healthcare professional.
Nicole Grassano, Host:Hello, and welcome to thePharmacy TimesNews Network. I’m Nicole Grassano your host for our Pharmacy Week in Review.
FDA officials have approved risperidone (Perseris, Indivior) for extended-release injectable suspension treatment of schizophrenia in adults, according to a statement,Pharmacy Timesreported. Risperidone is the first once-monthly subcutaneous risperidone-containing, long-acting injectable. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formulation process, according to Indivior. The approval is based on data from a phase 3 trial evaluating the efficacy and safety of risperidone. In an 8-week study of 354 patients, efficacy was demonstrated by an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale total score at day 57. There was also a statistically significant improvement in Clinical Global Impression Severity of Illness at day 57.
TheArchives of Disease in Childhood, Education and Practice Editionhas published a manuscript that describes a structured approach to chronic cough in children,Contemporary Clinicreported. These authors indicate that chronic cough has 5 etiologies. These are chronic cough in a normal child, chronic cough in a child with a serious underlying illness, upper airway cough syndrome (previously called postnasal drip syndrome), asthma syndrome, or psychogenic cough. The authors remind clinicians that a cough can occur pursuant to bacterial or viral respiratory infection. Some children develop a post infectious illness, often caused by mycoplasma, pertussis, or chlamydia. Some children may develop tuberculosis although it is rare. Atopic conditions (asthma and allergic rhinitis) are also notorious causes of cough.
Merck officials recently announced positive week 96 results from the phase 3 DRIVE-FORWARD study for its investigational HIV therapy doravirine (DOR) at the 22nd International AIDS Conference in Amsterdam, The Netherlands,Specialty Pharmacy Timesreported. DOR, a nonnucleoside reverse transcriptase inhibitor, is being evaluated for efficacy and safety in combination with other antiretroviral agents to treat HIV-1 infection in adult patients with no prior antiretroviral treatment history. In the trial, 766 treatment-naïve patients were randomized and received either DOR once daily (100 mg) or ritonavir-boosted darunavir (800 mg and 100 mg, respectively) once daily, each in combination with another drug. According to the data, at week 96, 73.1% of patients treated with once-daily DOR achieved viral suppression compared with 66% of patients treated with once-daily ritonavir-boosted darunavir (DVR+r).
Pharmacists may get more questions about XYZAL 24HR if their patients have seen a new commercial for the OTC antihistamine. In the spot, called “Be Wise All, Take XYZAL,” an owl wearing a monocle welcomes us to the Hall of Allergies and takes us on a stroll down memory lane. He explores how other OTC medicines compares with XYZAL, which offers 24-hour allergy relief. The owl insists that XYZAL lasts 6 times longer than Benadryl, works faster than Claritin, and provides the same relief as Zyrtec, though it is just half the size. When he grabs the box of XYZAL Allergy 24HR on display with his wing, a security guard asks him not to touch the exhibit.
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Thanks for watching our Pharmacy Week in Review. I’m Nicole Grassano at thePharmacy TimesNews Network.