November 2023

PDR Drug Update 

First Oral Selective 5HT1A Receptor Agonist for MDD

Depression is a leading cause of disability, with an estimated 21 million US adults experiencing at least one major depressive episode. Major depressive disorder (MDD) is associated with high mortality, most often due to suicide. It is imperative to identify effective therapies for patients diagnosed with mental health conditions. A brand-new approval of a first-in-class medication for MDD is a hopeful advancement in antidepressive therapy.

Despite MDD being a serious mental illness, it can be treated. Many patients have success with a combination of pharmacotherapy and psychotherapy. Individual patient response to pharmacotherapy can vary greatly, and full response time can take up to 12 weeks, though many do have improvement within one to two weeks. The recent FDA approval for Exxua (gepirone) for the treatment of MDD in adults offers a novel therapy class as the first antidepressant that selectively targets serotonin (5HT) 1A receptors. The medication is an important addition to the options available for prescribers. A wider range of treatment types can help providers pinpoint the most effective therapies for individual patients. Exxua’s characteristics include the ability to address the symptoms of MDD without the adverse effects of sexual dysfunction or weight gain that are typically associated with similar medications. The drug is not approved for use in children. All patients treated with antidepressants need to be monitored closely in order to identify any clinical worsening or development of suicidal thoughts and behaviors.

Since patients frequently first speak to their primary care physicians about symptoms of depression they may be experiencing, it is important for providers to be well-versed in the disorder's characteristics and be able to discuss treatment options to determine the appropriate approach. According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), a major depressive episode is constituted by a period of at least two continuous weeks where a patient has experienced five or more of the following symptoms, where one is either a depressed mood or decreased interest or pleasure in daily activities that they previously enjoyed:
  • Depressed mood for most of the day
  • Markedly diminished interest or pleasure in all or almost all activities most days
  • Significant weight gain or loss or decreased or increased appetite
  • Insomnia (often sleep-maintenance insomnia) or hypersomnia
  • Psychomotor agitation or retardation observed by others (not self-reported)
  • Fatigue or loss of energy
  • Feelings of worthlessness or excessive or inappropriate guilt
  • Diminished ability to think or concentrate or indecisiveness
  • Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, a specific suicide plan, or a suicide attempt
Additional criteria to determine MDD are that the patient's symptoms are causing significant distress or functional impairment and that an episode is not attributable to the physiological effects of another medical condition (eg, thyroid or adrenal gland disorders, brain tumors, stroke, Parkinson’s disease, multiple sclerosis, AIDS) or use of certain drugs. Clinical evaluation should include checks of CBC and levels for electrolytes, TSH, B12, and folate. The Patient Health Questionnaire (PHQ-9) is a standard screening tool used as part of the dialogue with the patient to understand and scale the symptoms they are experiencing in order to help diagnose depression.

As mental health therapies continue to evolve, stay informed about critical drug information, including targeted therapies for MDD, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, available for free from your preferred app store.

FDA New Approvals

Adzynma

The FDA has approved Adzynma (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). Learn more about Adzynma

Agamree

The FDA has approved Agamree (vamorolone) oral suspension 40mg/mL for the treatment of Duchenne muscular dystrophy in patients aged 2 years and older. Learn more about Agamree

Defencath

The FDA has approved Defencath (heparin/taurolidine) catheter lock solution to reduce the incidence of catheter-related bloodstream infections for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. Learn more about Defencath

Fruzaqla

The FDA has approved Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Learn more about Fruzaqla

Ixchiq

The FDA has approved Ixchiq, a single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals aged 18 years and older who are at increased risk of exposure to CHIKV. Learn more about Ixchiq

Loqtorzi

The FDA has approved Loqtorzi (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Learn more about Loqtorzi

Omvoh

The FDA has approved Omvoh (mirikizumab-mrkz) infusion (300mg/15mL)/injection (100mg/mL), the first and only interleukin-23p19 antagonist for the treatment of moderately to severely active ulcerative colitis in adults. Learn more about Omvoh

Wezlana

The FDA has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis, and pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis. Learn more about Wezlana

Zepbound

The FDA has approved Zepbound (tirzepatide) injection for adults with obesity (with a BMI of 30kg/m2 or greater) or those who are overweight (with a BMI of 27kg/m2 or greater) and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease, to lose weight and keep it off. Learn more about Zepbound

Zituvimet

The FDA has approved Zituvimet (metformin HCl/sitagliptin) tablets 500mg/50mg and 1000mg/50mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Learn more about Zituvimet

Zymfentra

The FDA has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab product administered intravenously. Learn more about Zymfentra

FDA New Indications

Cosentyx

The FDA has approved Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A, a cytokine believed to be involved in the inflammation of HS. Learn more about Cosentyx

Exparel

The FDA has approved the Exparel (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. Learn more about Exparel

Keytruda

The FDA has approved Keytruda (pembrolizumab) plus gemcitabine and cisplatin as treatment for patients with locally advanced unresectable or metastatic biliary tract cancer. Learn more about Keytruda

Tibsovo

The FDA has approved Tibsovo (ivosidenib) for adults with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test. Learn more about Tibsovo

Vabysmo

The FDA has approved Vabysmo (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema. Learn more about Vabysmo

FDA New Formulations

Voquezna

The FDA has approved reformulation of vonoprazan tablets for both Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori infection in adults. Learn more about Voquezna

FDA Recalls

Cardinal Health Ophthalmic Products

Cardinal Health, Inc. is initiating a voluntary recall for all lots of ophthalmic products supplied by Velocity Pharma, to the consumer level. Cardinal Health, Inc. received information from the FDA indicating that investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas. Learn more about the Cardinal Health ophthalmic products recall

The Harvard Drug Group Ophthalmic Products

The Harvard Drug Group, d/b/a Major Pharmaceutical and Rugby Laboratories, is initiating a voluntary recall for all lots of polyvinyl alcohol, 1.4% lubricating eye drops, and lubricating tears eye drops (dextran/hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, to the consumer level. The Harvard Drug Group received information from the FDA indicating that its investigation found unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. Learn more about the Harvard Drug Group ophthalmic products recall

Kilitch Healthcare India Limited Ophthalmic Products

Kilitch Healthcare India Limited is voluntarily recalling multiple eye drops products to the consumer level with all lots within expiry, with expiration dates ranging from November 2023 to September 2025. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. Learn more about the Kilitch Healthcare India Limited ophthalmic products recall

SugarMDs Dietary Supplement

SugarMDs is voluntarily recalling lot: 22165-003 advance glucose support supplement in 60-, 120- and 180-count bottles, to the consumer level. FDA analysis has found the product to be tainted with glyburide and metformin. Glyburide and metformin are active ingredients found in several FDA-approved prescription drugs used to treat type 2 diabetes. Products containing glyburide and metformin cannot be marketed as dietary supplements. Learn more about the SugarMDs dietary supplement recall