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Weekly Drug News Round-Up: November 7, 2018

Potent Pain Drug Dsuvia Approved Under Restricted Use

Dsuvia is a sublingual sufentanil tablet under tight control via the Dsuvia REMS Program due to the possibility of fatal respiratory depression Read More...

On Friday, the FDA approved AcelRx Pharmaceuticals Dsuvia (sufentanil), a potent opioid for severe acute pain and for which alternative treatments are inadequate. Much controversy surrounds this approval, including the question of why another opioid is needed when rampant opioid abuse continues to engulf the United States. The FDA has addressed many of these concerns.

  • Dsuvia is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator given under the tongue (sublingual) by a healthcare professional and only in a certified, medically-supervised setting.
  • The FDA advisory committee discussion centered around the need for populations who are not able to swallow oral medication and where access to intravenous (IV) pain relief is not possible; for example, soldiers on the battlefield or in the operating room, a high priority for the Pentagon.
  • Dsuvia is reserved for use in patients for whom there are no alternative pain treatment options.
  • The Dsuvia REMS mandates that the drug is only available in a certified medically-supervised health care setting (i.e., hospitals, surgical centers, and emergency departments), including its use on the battlefield, and must be given by a healthcare provider.
  • Dsuvia is not available in retail pharmacy settings. Dsuvia is not dispensed directly to patients for use at home and should not be used for more than 72 hours. This drug is only given by a health care provider using a single-dose applicator.
  • Common side effects of Dsuvia include nausea, headache, vomiting, dizziness and hypotension (low blood pressure).

Pfizer’s Lorbrena Cleared for Non-Small Cell Lung Cancer

Lorbrena is a new option for NSCLC patients who have progressed but provides an opportunity to remain on oral therapy Read More...

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) now approved for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on other ALK TKIs.

  • The recommended dosage is 100 mg orally once daily.
  • In studies, overall response rate was 48%, including 57% of patients who had previous treatment with more than one ALK TKI. In the trial, 69% of patients had a history of brain metastases and the intracranial response rate was 60%.
  • The most common side effects included edema (swelling), peripheral neuropathy (nerve pain), cognitive (thinking, learning, memory) effects, and dyspnea (shortness of breath), among others.

Udenyca Approved As Second Biosimilar to Neulasta

A biosimilar is highly similar to an FDA-approved biologic with no clinically meaningful differences Read More...

Udenyca (pegfilgrastim-cbqv), from Coherus BioSciences, is a PEGylated growth colony-stimulating factor and the second biosimilar to Neulasta (pegfilgrastim). Colony stimulating factors are used in patients who are undergoing cancer treatment that causes low white blood cell counts (neutropenia) and puts the patient at risk of infection.

  • The approval of Udenyca was supported by pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.
  • The most common side effects with Udenyca at an incidence equal or greater than 5% when compared to placebo are bone pain and pain in extremity.
  • The first biosimilar to Amgen’s Neulasta was Fulphila (pegfilgrastim-jmbd) from Mylan and Biocon, approved in June 2018.

Sympazan Oral Film Approved for Seizures of Lennox-Gastaut Syndrome

Sympazan oral film is berry flavored and comes in 5 mg, 10 mg, and 20 mg dosages Read More...

The FDA has approved a new dosage form of clobazam known as Sympazan, from Aquestive Therapeutics. Sympazan is a benzodiazepine oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

  • LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or cognitive impact, and the oral film may be easier.
  • Clobazam is also available as the brand Onfi as either an oral tablet or suspension.
  • Generic formulations of Onfi have been FDA-approved but may not yet be commercially available.