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 May 30 2008, 11:44 AM
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Forum Super Administrator
Group: Super Administrators
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Joined: 1-December 01
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QUOTE Pristiq® ( Desvenlafaxine )
Desvenlafaxine succinate, marketed under the name Pristiq®, is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class from Wyeth. It is a metabolite of venlafaxine (Effexor®). Pristiq® is also being targeted as the first non-hormonal based treatment for menopause.[1]
Approval status
Wyeth announced on 23 January 2007 that it received an "approvable" letter from the Food and Drug Administration for desvenlafaxine. Final approval to sell the drug was contingent on a number of things, including:
* a satisfactory FDA inspection of Wyeth's Guayama, Puerto Rico facility, where the drug is to be manufactured;
* several post-marketing commitments;
* clarity by Wyeth around the company's product education plan for physicians and patients;
* approval of desvenlafaxine's proprietary name, Pristiq.[2]
The FDA approved the drug for antidepressant use in February 2008, and will be available in US pharmacies in May 2008.
Executive Summary
Desvenlafaxine succinate extended release tablets, (hereafter referred to as desvenlafaxine), is a norepinephrine/serotonin reuptake inhibitor. Desvenlafaxine is a synthetic form of a known active metabolite of venlafaxine.
Current Standard of Therapy
For Major Depressive Disorder (MDD), there is no single, gold standard treatment modality. The approach to treatment depends on patient preference, compliance, and practitioner assessment. For mild to severe depression without psychoses or suicidal ideation, psychotherapy, medications, or both are first line treatments. The specific pharmacotherapy choice depends on patient’s past experience, acceptance, and specific complaints (insomnia, somnolence, pain, etc.).5 Some common first line pharmacological agents include SSRI, TCAs, DNRTI, SNRI.5
Objective assessment of patient’s initial status and progress involved one of several surveys including AMSIT Mental Status Exam, Hamilton Depression Scale (HAM-D17), and a Depression Inventory. Adequate response to therapy is defined as a >=50% reduction in Depression scores. Stages of Major Depressive Episode Treatment include Acute (12wks), Continuation (4-9 months) and Maintenance Phases. Typical therapy lasts not only for the acute phase, but is maintained for an additional 16-36 weeks during the continuation phase. Only after the continuation phase is the discontinuation of therapy considered. 5,6
Side Effects
Side effect profiles were consistent for all three studies evaluated, with nausea being the most profound and prevalent. Although rates varied substantially from study to study, nausea was consistently the most common complaint (30-50% vs placebo 9-11%) and the most common reason for discontinuation2,3,4. Suicidal ideation was monitored and was determined to be significant in 1-2 patients in each study2,3,4. Other common side effects were dry mouth, sweating, dizziness, fatigue, constipation, anorexia, and sexual dysfunction. These side effect patterns are consistent with other SNRIs venlafaxine and cymbalta.7,8 Relative rates are not available, as there were no head to head studies.
Clinical Efficacy
Internal Validity
In published phase III Trials, desvenlafaxine was compared only to placebo. In these trials, primary endpoints were powered to measure a reduction in depression (HAM-D17) scores2,3,4, not the standard response measure of >=50% reduction in depression scores6.
Response scores were secondary measures, which the studies may or may not have been powered to address. These trials showed dose-erratic reductions in HAM-D17 scores, which undermined the results. Response rates varied from 43-60%, which is lower than most current antidepressants, which have a 60-70% response rate.6 Remission rates of 23-37% for desvenlafaxine are also lower than other antidepressant rates of 30-40%. Of course, generalizations of this nature cannot be made without careful statistical testing, which was beyond the scope of this project.
Treatment duration for the three reviewed trials seemed inadequate, given the staging of MDD. MDD acute phase lasts 12 weeks, while all three reviewed studies only treated patients for 8 weeks.5,6 Although it may not be practical or required to continue therapy for an entire year during a study, it is difficult to determine if desvenlafaxine is an appropriate therapy without these data.
External Validity
There may be some differences in efficacy across ethnic backgrounds. One study, with three different dose strengths, showed efficacy in the 100mg and 400mg doses, but no efficacy in the 200mg dose2. This group had a notably higher proportion of blacks and Hispanics than the other two active groups. The only other study which listed ethnic distributions had a notably higher proportion of blacks and Hispanics in the placebo group vs. the active group. Although kinetic studies have indicated there are no know active metabolites for desvenlafaxine, the possibility of ethnic variations in response cannot be ruled out.1
Systematic (IUPAC) name
4-[2-dimethylamino-1-(1-hydroxycyclohexyl)
ethyl]phenol
Identifiers
CAS number 93413-62-8
ATC code N06AX23
PubChem 125017
Chemical data
Formula C16H25NO2
Mol. mass 263.375 g/mol
Synonyms O-desmethylvenlafaxine
Norvenlafaxine
Pharmacokinetic data
Bioavailability C
Protein binding high >90%
Metabolism CYP1A2 and CYP 2D6
Half life 12 hours
Excretion ?
Therapeutic considerations
Licence data
US
Pregnancy cat.
Legal status
℞-only(US)
Routes Oral
References
1 Desvenlafaxine package insert. Philadelphia, PA; Wyeth; 2/2008
2 DeMartinis NA, Yeung PP, Entsuah R, Manley AL.A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007;68(5):677-88.
3 Liebowitz MR, Yeung PP, Entsuah R. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. J Clin Psychiatry. 2007;68(11):1663-72
4 Septien-Velez L, Pitrosky B, Padmanabhan SK, Germain JM, Tourian KA. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2007;22(6):338-47
5 Karasu, TB, Gelenberg, A, Meriam, A, Wang, P. Practice Guideline for the Treatment of Patients With Major Depressive Disorder, Second Edition.. American Psychiatric Association. Retrieved from http://www.psychiatryonline.com/content.aspx?aid=48690 on 04/22/08
6 Applied Therapeutics: The Clinical Use of Drugs 8th ed. Koda-Kimble, MA, Young, LY, Kradjan, WA, Guglielmo, BJ, Alldredge, BK, Corelli, RL. Lippincott Williams & Wilkins 2005
7 Effexor XR package insert. Philadelphia, PA; Wyeth, 2/2008
8 Cymbalta package insert. Indianapolis, IN; Eli Lilly 12/2007
9 Comparison of commonly used antidepressants. Pharmacist’s Letter/Prescriber’s Letter 2008;24(5):240509. Retrieved from http://www.pharmacistsletter.com/(S(ok22th...NT&s=PL on 04/24/2008
1. ^ (July 24,2007). "Wyeth Receives Approvable Letter From FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated With Menopause". Press release.
2. ^ (January 23, 2007). "Wyeth Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder". Press release. Retrieved on 2007-04-04.
3. ^ Wyeth (February 29, 2008). "FDA Approves Pristiq". Press release. Retrieved on 2008-02-29.
External links
* Pristiq Official Site
--------------------
Be Well....
~Lindsay ♥, Forum Super Administrator
Founder, depressionforums.org
Forum Super AdministratorDF member since Dec 2001  ---- "I cannot make my mark for all time...those concepts are mutually exclusive.
"Lasting effect" is a self -contradictory term. Meaning does not exist in the future, nor do I.
Nothing will have meaning, "ultimately."
Nothing will even mean tomorrow what it did today. Meaning changes with the context.
My meaningfulness is in the here and now. It is enough that I may be of value to someone today.
It is enough that I make a difference now." ~Lindsay
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Oct 19 2008, 11:46 AM
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Admin Team
Group: Super Administrators
Posts: 10,658
Joined: 15-June 04
From: United States
Member No.: 4
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Pristiq
Generic Name: desvenlafaxine (des VEN la FAX een)
Brand Names: Pristiq
What is Pristiq?
Pristiq is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems.
Pristiq is used to treat major depressive disorder.
Pristiq may also be used for other purposes not listed in this medication guide.
Important information about Pristiq
Do not take Pristiq if you are allergic to desvenlafaxine or venlafaxine (Effexor), or if you are also using a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Pristiq. After you stop taking Pristiq, you must wait at least 7 days before you start taking an MAOI.
You should not take Pristiq together with venlafaxine (Effexor).
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Avoid drinking alcohol, which can increase some of the side effects of Pristiq. It may take several weeks or more for your symptoms to improve. For best results, keep using the medication as directed. Do not stop using Pristiq without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
Before taking Pristiq
Do not take Pristiq if you are allergic to desvenlafaxine or venlafaxine (Effexor), or if you are also using a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Pristiq. After you stop taking Pristiq, you must wait at least 7 days before you start taking an MAOI.
You should not take Pristiq together with venlafaxine (Effexor).
If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Pristiq, tell your doctor if you have:
*
bipolar disorder (manic depression);
* liver disease;
* kidney disease;
*
heart disease or high blood pressure;
*
a history of stroke;
*
glaucoma;
*
seizures or epilepsy;
*
a bleeding or blood clotting disorder; or
*
high cholesterol.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category C. Pristiq may be harmful to an unborn baby, and may cause problems in a newborn baby if the mother takes the medication late in pregnancy (during the third trimester). Tell your doctor if you are pregnant or plan to become pregnant during treatment. Pristiq can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor.
How should I take Pristiq?
Take Pristiq exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medication with a full glass of water. You may take Pristiq with or without food. Do not crush, chew, break, or dissolve the extended-release tablet. Swallow the pill whole. Breaking or dissolving the pill may cause too much of the drug to be released into the body at one time.
Try to take Pristiq at the same time each day.
The Pristiq tablet is made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of Pristiq and will not make the medication less effective.
It may take several weeks or more for your symptoms to improve. For best results, keep using the medication as directed. Do not stop using Pristiq without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. Store Pristiq at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication.
Overdose symptoms may include headache, dizziness, agitation, dry mouth, vomiting, diarrhea, fast heart rate, and numbness or tingly feeling.
What should I avoid while taking Pristiq?
Avoid drinking alcohol, which can increase some of the side effects of Pristiq.
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by Pristiq.
Pristiq can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Pristiq side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
*
seizure (convulsions);
*
cough, chest tightness, trouble breathing;
*
easy bruising or bleeding (nosebleeds, bleeding gums), ****** or tarry stools, coughing up blood;
*
increased blood pressure (severe headache, vision problems, buzzing in your ears, shortness of breath, uneven heartbeats);
*
low sodium levels in the blood (nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure); or
*
serotonin syndrome (restlessness, high fever, nausea, vomiting, diarrhea, fast heartbeat, sweating, loss of coordination, overactive reflexes, hallucinations, or fainting).
Less serious side effects may include:
*
drowsiness, dizziness, anxiety;
*
dry mouth, loss of appetite;
*
constipation;
*
decreased sex drive, impotence, or difficulty having an orgasm;
*
mild headache, blurred vision; or
*
tremor.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
What other drugs will affect Pristiq?
Tell your doctor about all other medications you use, especially:
*
a blood thinner such as warfarin (Coumadin);
*
ketoconazole (Nizoral);
*
linezolid (Zyvox);
*
lithium (Eskalith, Lithobid);
*
sibutramine (Meridia);
*
St. John's wort;
*
tramadol (Ultram);
*
tryptophan (sometimes called L-tryptophan);
*
migraine headache medication such as almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
*
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or
*
any other antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), or trimipramine (Surmontil).
This list is not complete and there may be other drugs that can interact with Pristiq. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
* Your pharmacist can provide more information about Pristiq.
* Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
* Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2008 Cerner Multum, Inc. Version: 1.01. Revision Date: 05/16/2008 12:22:41 PM.
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~Lindsay, Forum Super Administrator, Founder  Hotlines
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Pristiq® (desvenlafaxine) FAQ'S |
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Depression Forums - A Depression & Mental Health Community Support Group > DEPRESSION & ANXIETY MEDICATIONS - LOOKING FOR ANSWERS > Effexor® (Venlafaxine) / Pristiq® (desvenlafaxine)
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