What is samidorphan used for?
Samidorphan is indicated in combination with olanzapine for the treatment of bipolar I disorder, either as an adjunct to lithium or valproate or as monotherapy for the acute treatment of manic or mixed episodes or as maintenance therapy, and for the treatment of schizophrenia in adults.
What company makes vivitrol?
Alkermes
Vivitrol, manufactured by the drug company Alkermes, is one of a handful of medications used to treat opioid addiction.
Who owns Aristada?
Aristada FDA Approval History Company: Alkermes, Inc.
Is samidorphan available in the US?
samidorphan. Samidorphan is not currently available or marketed in any country.
Is Samidorphan approved?
The oral combination olanzapine and samidorphan (Lybalvi) has been approved by the FDA for the treatment of adults with schizophrenia or bipolar I disorder as a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
What are the side effects of Samidorphan?
What are some other side effects of this drug?
- Feeling dizzy, sleepy, tired, or weak.
- Shakiness.
- Headache.
- Constipation.
- Dry mouth.
- Weight gain.
- More hungry.
- Back pain.
What drugs make Alkermes?
Among these products, five are primary to the company: risperidone long-acting Injection (generic for Risperdal Consta) for schizophrenia and bipolar 1 disorder, paliperidone palmitate (generic for Invega Sustenna in the U.S., Xeplion in Europe) for schizophrenia, 4-aminopyridine (generic for Ampyra in the U.S..
How long has VIVITROL been out?
Vivitrol, initially approved by the FDA in 2006 for treating alcohol dependence, is known as an opiate antagonist, meaning it blocks the effects of opiates by occupying the opiate receptor sites in the brain.
Is Aristada the same as Abilify?
Aristada and Aristada Initio are both aripiprazole lauroxil injections, the long-acting version of Abilify (aripiprazole) used to treat schizophrenia. Aristada Initio is used as a loading dose to jumpstart your treatment on Aristada.
Is Abilify and Aristada the same thing?
Abilify Maintena contains the active ingredient aripiprazole. These two active ingredients aren’t exactly the same. After you take Aristada, your body turns the prodrug* aripiprazole lauroxil into aripiprazole. Both Aristada and Abilify Maintena belong to a drug class called antipsychotic drugs.
Is samidorphan approved?
Is samidorphan a controlled substance?
Samidorphan is currently a schedule II controlled substance because it can be derived from opium alkaloids.
What is the AUC of samidorphan?
Upon reaching steady-state, with a once-daily dose of 10 mg samidorphan combined with 20 mg olanzapine, samidorphan has a mean C max of 45.1 ± 11.4 ng/mL and an AUC 24h of 364 ± 112 ng*h/mL. Samidorphan has an absolute oral bioavailability of 69% and a T max of 1-2 hours. 8, 9, 11
What is Alkermes AlkS 5461?
Company: Alkermes, Inc. ALKS 5461 (buprenorphine and samidorphan) is a novel opioid modulator, combining a partial opioid agonist with an opioid antagonist to rebalance brain function in patients with treatment-resistant depression. Development Status and FDA Approval Process for ALKS 5461.
Notified of marketing changes. Samidorphan is a novel opioid-system modulator, similar to naltrexone, that functions primarily as a μ-opioid receptor antagonist in vivo and is used primarily in combination with antipsychotics to reduce their metabolic dysfunction-associated adverse effects.
Does food affect samidorphan pharmacokinetics?
Food has only a minor effect on samidorphan pharmacokinetics. dosage, form, labeller, route of administration, and marketing period. Access drug product information from over 10 global regions. This compound belongs to the class of organic compounds known as phenanthrenes and derivatives.