Product
Pristiq
Approval Date
February 29, 2008
Release Date
Second Quarter of 2008
Company
Wyeth Pharmaceuticals
Class
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Indication
Major Depressive Disorder (MDD)
Active Ingredient
Desvenlafaxine
Agency Roster
Quicksilver Science
Euro RSCG Life Chelsea
Euro RSCG Life x2
MarketingStrategy/Execution
Wyeth is expected to mount a large sales campaign for Pristiq,a successor drug to Effexor XR, Wyeth’s top-selling SNRI whose patent expiresin 2010. Its NDA delayed by a year at the FDA, the company is anxious to jumpout of the gate and said it will introduce the new antidepressant topsychiatrists and primary care doctors beginning early in the second quarter.Pristiq will be positioned as a new therapeutic option, as the approvedonce-daily, 50-mg dose can be given immediately, without the need for titrationas with other SNRIs including Effexor. The lower dose may also confer a bettertolerability profile that competitors. Some analysts are skeptical that Pristiqreally is substantially different from other marketed antidepressant, though,and this may limit sales. Another competing factor will be the predecessordrug, Effexor, but discounting the price of Pristiq would suppress that threat.The company continues to test Pristiq as a treatment for vasomotor symptoms inpostmenopausal women, with approval not possible until mid-2009 at theearliest.
The Market
| SNRI US sales ($000s) last 5 years | |
| 2007 | $5,009,192 |
| 2006 | $4,069,249 |
| 2005 | $3,402,347 |
| 2004 | $2,856,330 |
| 2003 | $2,282,600 |
| Source: IMS Health, Mar. 2008 |
|
| Top 4 SNRIs | ||
| Total ’07 US sales ($000s) | % sales growth over total ‘06 | |
| EFFEXOR XR (Wyeth) |
$2,867,030 | 8% |
| CYMBALTA (Lilly) |
$1,968,637 | 57% |
| VENLAFAXINE HCL (Wyeth) | $1,614,129 | 267% |
| EFFEXOR ( Wyeth) |
$19,395 | -83% |
| |
|
|
| Source: IMS Health, Mar. 2008 |
||
Physician Outlook
Pristiq is an SNRI (serotonin norepinephrine reuptakeinhibitor) and the follow-on drug to Wyeth’s successful Effexor XR brand.Research among MCO/PBM decision-makers shows Effexor XR has preferred statusamong many plans given its position as an important alternative treatment tothe SSRI class of anti-depressant. So much will depend on Wyeth’s abilityto leverage this very positive Effexor XR position in their Pristiq MCO/PBMcontracting.
— Geoff Penney, VP, category business leader, psychiatry,GfK Market Measures
Also in the Pipeline(according to Adis R&D Insight)
Drug: Wellbutrin
Manufacturer: GlaxoSmithKline
Indication:Depression
Active Ingredient:Bupropion
Phase: Preregistration
Drug: Seroquel
Manufacturer: AstraZeneca
Indication:Generalized Anxiety Disorder
Active Ingredient:Quetiapine
Phase: III
Drug: Norebox
Manufacturer: Pfizer
Indication:Depression
Active Ingredient:Reboxetine
Phase: Preregistration
Source: Wolters Kluwer Health
Recent MM&MCoverage
Business briefs
FDAdelays action on Wyeth’s Pristiq
Wyethmulls slashing workforce by 10%
Pipelineproblems for Wyeth
Product News
Productnews from the 01/30/07 Newsbrief
Approvalof Wyeth antidepressant delayed
Productnews from the 04/24/07 news brief
Clinical Trials
Four 8-week, double-blind, placebo-controlled fixed-dose studies wereconducted to assess the efficacy and safety of desvenlafaxine intreating major depressive disorder. The first study compareddesvenlafaxine 100mg, 200mg, and 400mg once daily to placebo. In asecond study, patients received desvenlafaxine 200mg or 400mg oncedaily or placebo, and in two other studies, patients were givendesvenlafaxine 50mg or 100mg once daily or placebo. Desvenlafaxine wasshown to be better than placebo, as measured by improvement using the17-item Hamilton Rating Scale for Depression score in four studies, andit was better than placebo in overall improvement (measured by theClinical Global Impressions Scale-Improvement) in three of the fourstudies. Doses above 50mg/day were not shown to be more effective, butadverse reactions and discontinuations were more frequent at the higherdose.
Adverse Reactions
GI upset, dizziness, insomnia, hyperhidrosis, constipation, somnolence,decreased appetite, anxiety, sexual dysfunction; rare:hyponatremia/SIADH (esp in elderly), interstitial lung disease,eosinophilic pneumonia, serotonin syndrome, mydriasis.
Adults
Swallow whole. 50mg once daily. Severe renal impairment (CrCl<30mL/min), ESRD: 50mg every other day. Do not give supplementaldose after dialysis. Moderate renal impairment: max 50mg/day. Hepaticimpairment: max 100mg/day. Withdraw gradually.
Children
Not recommended.
Contraindications
MAOIs: see Interactions.
Precautions
Monitor BP; reduce dose or discontinue if elevated BP persists. Cardio-or cerebrovascular disease. Hypercholesterolemia. Increased intraocularpressure. Mania/hypomania. Severe renal dysfunction. Seizure disorder.Reevaluate periodically. Suicidal ideation. Write prescription forsmallest practical amount. Elderly. Labor & delivery. Pregnancy(Cat.C; avoid in 3rd trimester; taper). Nursing mothers: notrecommended.
Interactions
Allow =14 days after MAOI discontinuance before startingdesvenlafaxine; allow =7 days after desvenlafaxine discontinuancebefore starting an MAOI. Avoid alcohol, concomitant venlafaxine, otherforms of desvenlafaxine. Concomitant serotonin precursors (eg,tryptophan): not recommended. May potentiate anticoagulants. Monitorfor serotonin syndrome with SSRIs, SNRIs, triptans. May be potentiatedby potent CYP3A4 inhibitors. May antagonize CYP3A4 substrates. Cautionwith serotonergics, other CNS-active drugs.
