Osmolex ER Approved to Treat Parkinson
February 16, 2018 – The U.S. FDA has approved Osmolex ER™ (amantadine) tablets, manufactured by Osmotica Pharmaceuticals, to treat adult patients who have Parkinson’s disease, as well as to relieve extrapyramidal side effects (muscle spasms, tremors, and other motor disorders) associated with the use of other drugs, such as antipsychotic medications.
Osmolex ER is a once-a-day medication that contains a combination of immediate and extended release amantadine. Recommended dosing is 129mg each morning to start. Dosage can be increased at weekly intervals if needed, up to a maximum of 322mg per day. The tablets should not be cut, crushed, or otherwise altered. For patients with renal impairment, modified dosing may be required. Osmolex ER will be available in 129mg, 193mg, and 258mg tablets.
Osmotica has not yet announced pricing or launch plans.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.