Authorized Generic Available for Xyrem
On Jan. 3, 2023, Hikma Pharmaceuticals disclosed that it has introduced sodium oxybate oral solution, 0.5gm/mL, an authorized generic (AG) to Xyrem® (Jazz), in the U.S. Sodium oxybate is indicated to treat narcolepsy-related cataplexy (sudden loss of muscle tone, but not consciousness) and excessive daytime sleepiness (EDS) for patients who are at least seven years old. After small starting doses, which are weight-based for children, it must be increased gradually to a recommended daily range of 6gm to 9gm. The total dose is divided into two equal parts that each are diluted with about one-fourth cup of water. Following two hours or more without eating, the first dose is taken as soon as the patient is in bed; and the second between two-and-one-half and five hours later. A C-III controlled substance, it carries a boxed warning that taking it while drinking alcohol and/or using central nervous system (CNS) depressants (such as antipsychotics, benzodiazepines, opioids, or sedating antidepressants) can significantly affect consciousness and can lead to severe breathing problems. Hikma has 180 days of exclusivity before any other sodium oxybate product can be released to the U.S. For 2021, the net sales of Xyrem totaled approximately $1.3 billion.
New Dispensing Options for Mifepristone
On Jan. 3, 2023, the U.S. Food and Drug Administration (FDA) officially amended its requirements for dispensing Mifeprex® (mifepristone) tablets and its generic to include certified retail and home-delivery pharmacies. Used in combination with Cytotec® (misoprostol, generics), mifepristone induces abortions for women who have been pregnant for 10 weeks or less. Although dispensing rules were relaxed temporarily by a lawsuit and the COVID-19 public health emergency, access to mifepristone previously was limited mainly to direct dispensing to the patient by the prescriber in a medical facility. A REMS is in place to assure mifepristone is used appropriately. Patients must still have a prescription from a healthcare provider who is certified to manage abortions, and the pharmacy also must have certification from the FDA to handle the drugs. Both patients and prescribers are required to sign agreement forms, as well. The patient no longer needs to see the prescriber in person, however; telehealth visits may be used and if state laws allow. Additionally, mifepristone and misoprostol can be sent through private carriers, such as FedEx and UPS, and through the U.S. Postal Service (USPS) to all U.S. states. See the FDA’s information page and their FAQ site for details about the changes.