PDR Drug Update - July 2025

Novel Rescue Medications for Migraine

Patients who experience acute migraine often must cope with intense, throbbing head pain lasting for hours or several days. With over 42 million individuals in the US and several billion individuals globally affected by migraines, the disease ranks as the third most common worldwide illness. Additional symptoms can accompany the pain of an attack, commonly nausea, vomiting, light or sound sensitivity, and visual disturbances known as auras. As a result, the quality of life for migraine patients can be strongly diminished. Providers will need to work with patients to identify the frequency and severity of the headaches, if any additional symptoms occur, and any other existing medical conditions to be able to establish an effective treatment plan. Recent FDA approval of two new medications for acute treatment of migraine widens the options for helping patients fight against migraine attacks.

There is currently no cure for migraines. Treatment should first start with lifestyle changes. This includes eliminating known triggers, getting sufficient sleep, not missing meals, and reducing stress. Beyond those steps, a variety of medication types are available that can be used to help patients manage life with recurrent migraine. Medications for migraine treatment are categorized into two groups: pain-relieving medications (also known as acute or abortive treatments), which are taken during migraine attacks and aimed at stopping symptoms, and preventative medications. Mild-to-moderate migraine attacks are typically addressed with analgesics such as NSAIDs. Moderate-to-severe attacks are managed with migraine-specific treatment, including dihydroergotamine, or DHE. The drug has been used for decades to address acute migraine attacks. It is an alpha-adrenergic blocker with arterial vasoconstrictor and venoconstrictor properties. It is also a potent 5-HT 1b/1d receptor agonist.

Treatment with DHE is beneficial in several ways. It is quick-acting and available in non-oral forms, which is desirable for patients who have a difficult time swallowing pills. DHE’s effectiveness is also demonstrated through the low rates of migraine returning within one day after using it for acute treatment of a migraine attack. The recent approval of Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine with or without aura in adults presents a new option for patients who are in need of relief from their condition. Atzumi combines a specialized delivery device with a powder formulation of DHE. Patients are able to self-administer the drug intranasally with a simple-to-use squeezable device.

Also new to the DHE options is Brekiya (dihydroergotamine mesylate) injection, the first and currently only autoinjector form of DHE, indicated for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. DHE injections traditionally have been given only in a medical setting, such as the ER. Now, patients for whom subcutaneous DHE is an effective aid for acute migraine attacks are able to self-administer their treatment.

Although there is no cure for migraines, new therapies such as Atzumi and Brekiya continue to emerge that are helpful new additions to the existing options for migraine management. Hopefully, as advancements in migraine therapies continue, patients will experience less-debilitating and less-frequent migraines, and consequently, the quality of their lives will improve. Stay informed about emergent drug information, including treatment options for migraine, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Andembry

The FDA has approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older. Learn more about Andembry

Enflonsia

The FDA has approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Learn more about Enflonsia

Ibtrozi

The FDA has approved Ibtrozi (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Learn more about Ibtrozi

Khindivi

The FDA has approved Khindivi (hydrocortisone) oral solution as a replacement therapy in pediatric patients aged five years and older with adrenocortical insufficiency. Khindivi is the only FDA-approved oral solution formulation of hydrocortisone. Learn more about Khindivi

Starjemza

The FDA has approved Starjemza (ustekinumab-hmny) injection, a biosimilar referencing Stelara (ustekinumab) injection. Learn more about Starjemza

Tryptyr

The FDA has approved Tryptyr (acoltremon) ophthalmic solution 0.003% for the treatment of signs and symptoms of dry eye disease. Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. Learn more about Tryptyr

Widaplik

The FDA has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. Learn more about Widaplik

Xifyrm

The FDA has approved Xifyrm (meloxicam) injection for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Learn more about Xifyrm

Yeztugo

Yeztugo The FDA has approved Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first twice-yearly option available in the US for people who need or want PrEP. Learn more about Yeztugo

Yutrepia

The FDA has approved Yutrepia (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability. Learn more about Yutrepia

Zusduri

The FDA has approved Zusduri (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Learn more about Zusduri

FDA New Indications

Datroway

The FDA has approved Datroway (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy. Learn more about Datroway

Dupixent

The FDA has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid. Dupixent is now approved in the US to treat eight distinct diseases with underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system that affect a broad range of patients, from infants to elderly people. Learn more about Dupixent

Keytruda

The FDA has approved Keytruda (pembrolizumab) for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent. Learn more about Keytruda

Mavyret

The FDA has approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral therapy. It is now approved for the treatment of adults and pediatric patients aged three years and older with acute or chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis. Learn more about Mavyret

MenQuadfi

The FDA has approved an expanded indication of the quadrivalent meningococcal vaccine MenQuadfi, for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y, to include children aged 6 weeks to 23 months. Learn more about MenQuadfi

Monjuvi

The FDA has approved Monjuvi (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma. Learn more about Monjuvi

mRESVIA

The FDA has approved mRESVIA (mRNA-1345), respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals aged 18-59 years who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. Learn more about mRESVIA

Nubeqa

The FDA has approved Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer. Learn more about Nubeqa

FDA New Formulations

Brukinsa

The FDA has approved a new tablet formulation of Brukinsa (zanubrutinib) for all five approved indications. The new Brukinsa tablets are 160mg each, allowing patients to take two tablets daily rather than four of the current 80mg capsules. Additionally, Brukinsa tablets are smaller than the capsules and have a film coating, making them easier to swallow. Learn more about Brukinsa

FDA Recalls

Amneal Sulfamethoxazole/Trimethoprim

Amneal Pharmaceutical LLC is recalling three lots of sulfamethoxazole/trimethoprim tablets, USP, 400mg/80mg, to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint. Learn more about the Amneal sulfamethoxazole/trimethoprim recall

Church & Dwight Zicam and Orajel

Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Learn more about the Church & Dwight Zicam and Orajel recall

FDA Alerts

Complications with Transderm Scōp

The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children aged 17 years and younger and in adults aged 60 years and older, who may be sensitive to body temperature control disturbances. As a result, the FDA required that the Transderm Scōp prescribing information be revised to include a warning and other information about this risk. Learn more about the Transderm Scōp drug safety communication

July 2025