Expanded Indication Approved for Tiglutik

The U.S. FDA has approved an expanded indication for Tiglutik® (riluzole) oral suspension, manufactured by ITF Pharma. Under the expansion, the product can now be administered via percutaneous endoscopic gastrostomy (PEG) tubes to treat amyotrophic lateral sclerosis (ALS).

ALS is a disease of the motor neurons that affects approximately 16,000 individuals in the United States. As motor neurons deteriorate and die off, the brain loses its ability to send signals to the body’s muscles. This causes progressive loss of voluntary movement, which often leads to difficulty swallowing and may necessitate the placement of a PEG tube to deliver nutrients, fluids, and medications directly to the stomach.

In a clinical study, Tiglutik oral suspension was found to be bioequivalent when administered via PEG tube compared to the previously approved oral route of administration. Recommended dosing is 50mg taken twice daily at least one hour before or two hours after a meal, with 12 hours between doses. The patient’s serum aminotransferases should be monitored before and during treatment.

Tiglutik’s active ingredient, riluzole, has been FDA approved to treat ALS since 1995.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

NuvaRing Generic Approved to Prevent Pregnancy

The U.S. FDA has approved Amneal Pharmaceuticals’ generic version of Merck’s NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring). Amneal’s generic will be marketed under the name EluRyng™ and is the first generic alternative to NuvaRing to become available on the U.S. market.

EluRyng is lightweight, flexible vaginal ring that releases a combination of estrogen and progestin hormones indicated for use by women to prevent pregnancy. Under the recommended dosing, the ring should be inserted into the vagina for three weeks of continuous use. After the third week, EluRyng should be removed for a ring-free interval that last seven days. A new ring must then be inserted according to the recommended dosing to continue contraception.

Patients are able to insert and remove EluRyng on their own. However, they should speak to their doctor about proper use and the best time to insert the ring, as this can vary depending on the patient’s medical history and history of contraceptive use. A black box warning cautions that women over 35 years old who smoke should not use EluRyng, as smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.

Amneal Pharmaceuticals has launched EluRyng at a wholesale acquisition cost of $148.32 per box, compared to $162.63 for NuvaRing.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.